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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00546416
Registration number
NCT00546416
Ethics application status
Date submitted
11/09/2000
Date registered
27/01/2003
Date last updated
25/03/2015
Titles & IDs
Public title
S0008: Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma
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Scientific title
Phase III Trial of High Dose Interferon Alfa 2-b Versus Cisplatin, Vinblastine, DTIC Plus IL-2 and Interferon in Patients With High Risk Melanoma
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Secondary ID [1]
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0
U10CA032102
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Secondary ID [2]
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0
S0008
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma (Skin)
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Unspecified Adult Solid Tumor, Protocol Specific
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0
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Unspecified Childhood Solid Tumor, Protocol Specific
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0
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Paget's Disease of Bone
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0
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Leukemia
0
0
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Cutaneous T Cell Lymphoma
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0
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Peripheral T Cell Lymphoma
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0
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Condition category
Condition code
Cancer
0
0
0
0
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Malignant melanoma
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Cancer
0
0
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0
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Breast
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Neurological
0
0
0
0
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Other neurological disorders
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Injuries and Accidents
0
0
0
0
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Poisoning
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Cancer
0
0
0
0
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Leukaemia - Acute leukaemia
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Cancer
0
0
0
0
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Leukaemia - Chronic leukaemia
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Cancer
0
0
0
0
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Children's - Leukaemia & Lymphoma
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Musculoskeletal
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0
0
0
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Other muscular and skeletal disorders
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Cancer
0
0
0
0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
0
0
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0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - interleukin-2
Treatment: Other - filgrastim
Treatment: Other - interferon alfa
Treatment: Drugs - cisplatin
Treatment: Drugs - dacarbazine
Treatment: Drugs - vinblastine
Treatment: Drugs - Zoledronic Acid
Treatment: Drugs - Risedronate
Treatment: Drugs - Placebo to Risedronate
Treatment: Drugs - Placebo to Zoledronic Acid
Treatment: Other - Calcium and Vitamin D
Experimental: AC followed by Docetaxel + Herceptin (AC?TH) - Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
Active comparator: Arm I - Patients receive interferon alfa IV on days 1-5 of weeks 1-4 followed by interferon alfa subcutaneously (SC) on days 1, 3, and 5 of weeks 5-52 in the absence of disease progression or unacceptable toxicity.
Experimental: Arm II - Patients receive cisplatin IV over 30 minutes followed by vinblastine IV on days 1-4. Patients also receive dacarbazine IV over 1 hour on day 1, interleukin-2 IV over 96 hours on days 1-4, and interferon alfa SC on days 1-5, 8, 10, and 12. In addition, patients receive filgrastim (G-CSF) SC on days 6-15. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Experimental: Docetaxel + Carboplatin + Herceptin (TCH) - Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
Experimental: Zoledronic Acid and Placebo to Risedronate - Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Active comparator: Risedronate and Placebo to Zoledronic Acid - Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Experimental: Peripheral T-cell Lymphoma (PTCL) - Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
Experimental: Cutaneous T-cell Lymphoma (CTCL) - Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
Treatment: Other: interleukin-2
Given IV
Treatment: Other: filgrastim
Given subcutaneously
Treatment: Other: interferon alfa
Given IV and subcutaneously
Treatment: Drugs: cisplatin
Given IV
Treatment: Drugs: dacarbazine
Given IV
Treatment: Drugs: vinblastine
Given IV
Treatment: Drugs: Zoledronic Acid
Zoledronic acid 5 mg in 5 mL of sterile water intravenous infusion.
Treatment: Drugs: Risedronate
Oral risedronate 30 mg capsules.
Treatment: Drugs: Placebo to Risedronate
Oral placebo of risedronate capsules.
Treatment: Drugs: Placebo to Zoledronic Acid
5 mL of sterile water one dose intravenous infusion.
Treatment: Other: Calcium and Vitamin D
Calcium and vitamin D supplements were supplied.
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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5-year Overall Survival
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Assessment method [1]
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Overall survival was measured from the date of registration to study until death from any cause with observations censored at the date of last contact for patients last known to be alive.
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Timepoint [1]
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Every three months for a year, every six months for years 2-5, annual for years 5-10
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Primary outcome [2]
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5-year Relapse-Free Survival
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Assessment method [2]
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Measured from date of registration to date of first observation of progressive disease or death due to any cause.
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Timepoint [2]
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Every three months for the first year, every 6 months for years 2-5, annually for years 6-10
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Primary outcome [3]
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Percentage of Participants With Disease Free Survival at 5 Years
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Assessment method [3]
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Disease Free Survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.
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Timepoint [3]
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From randomization until relapse or death or up to 5 years
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Primary outcome [4]
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Number of Patients Who Achieve Therapeutic Response at 6 Months.
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Assessment method [4]
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Therapeutic response is defined as a reduction of at least 75% from baseline (Visit 1) in total serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase at the end of six months.
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Timepoint [4]
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6 months
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Primary outcome [5]
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Number of Participants With a Response
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Assessment method [5]
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A rigorous composite assessment was employed with uni-dimensional measurements of skin and visceral disease sites assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) required clearing of all known disease sites. Partial response (PR) required documented response in skin (= 30% per RECIST) or lymph nodes (= 50% per the International Working Group (IWG) criteria, with response in both compartments for a determination of PR, IWG guidelines. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the IWG criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry.
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Timepoint [5]
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up to 56.5 days
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Primary outcome [6]
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Duration of Response (DOR)
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Assessment method [6]
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DOR is defined as the date response was noted until disease was no longer considered to be responding. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and the International Working Group Criteria (IWG).Complete response (CR) required clearing of all known disease sites. Partial response (PR) required documented response in skin (= 30% per RECIST) or lymph nodes (= 50% per the International Working Group (IWG) criteria, with response in both compartments for a determination of PR, IWG guidelines. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the IWG criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry.
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Timepoint [6]
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up to 127 months
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Secondary outcome [1]
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Toxicity
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Assessment method [1]
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Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event
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Timepoint [1]
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While on treatment, patients on the HDIFN arm were assessed weekly for the 1st month, then every 2 weeks for the 2nd month, then every 3 months therafter; patients on the biochemo arm were assessed daily for the 1st 5 days, then weekly thereafter.
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Secondary outcome [2]
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Percentage of Participants With Disease Free Survival at 10 Years
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Assessment method [2]
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Disease free survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.
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Timepoint [2]
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From randomization until relapse or death or up to 10 years
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Secondary outcome [3]
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Overall Survival- Percentage of Participants Who Survived at 10 Years
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Assessment method [3]
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Overall survival of the participants was measured from the date of randomization up to the date of death due to any cause. Overall survival was estimated using the Kaplan-Meier method.
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Timepoint [3]
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From randomization until death or up to 10 years
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Secondary outcome [4]
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Relative Change in Serum Alkaline Phosphatase (SAP) in Units Per Liter (U/L) at Day 28
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Assessment method [4]
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The percent change in serum alkaline phosphatase from baseline to day 28 was measured.
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Timepoint [4]
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Baseline and day 28
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Secondary outcome [5]
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Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10
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Assessment method [5]
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The percent change in serum C-telopeptide from baseline to day 10 was measured.
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Timepoint [5]
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Baseline and day 10
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Secondary outcome [6]
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Relative Change in Urine Alpha C-telopeptide (a-CTx) in ug/mmol at Day 10
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Assessment method [6]
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The percent change in urine alpha C-telopeptide from baseline to day 10 was measured.
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Timepoint [6]
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Baseline and day 10
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Secondary outcome [7]
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Time to First Therapeutic Response
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Assessment method [7]
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A therapeutic response was defined as a reduction of at least 75% from baseline (Visit 1) in serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase.
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Timepoint [7]
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182 days
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Secondary outcome [8]
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Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28 Relative to Baseline
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Assessment method [8]
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Normalization of serum alkaline phosphatase occurred if the serum alkaline phosphatase measurement fell within the normal range.
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Timepoint [8]
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Baseline and day 28
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Secondary outcome [9]
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Change in Pain Severity Score
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Assessment method [9]
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Change in pain severity score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.
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Timepoint [9]
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Baseline and day 182
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Secondary outcome [10]
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Change in Pain Interference Score
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Assessment method [10]
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Change in pain interference score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.
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Timepoint [10]
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Baseline and day 182
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Secondary outcome [11]
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Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period
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Assessment method [11]
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Extended observation period. A therapeutic response is defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess or normalization of serum alkaline phosphatase.
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Timepoint [11]
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8 years was the maximum
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Secondary outcome [12]
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Number of Participants With a Partial Disease Relapse During the Extended Observation Period
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Assessment method [12]
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Extended observation period. A partial disease relapse was defined as an increase in serum alkaline phosphatase \>= 50% from the serum alkaline phosphatase measurement at month 6 and at least 1.25 times the upper normal limit.
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Timepoint [12]
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8 years was the maximum
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Secondary outcome [13]
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Number of Participants With a Disease Relapse During the Extended Observation Period
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Assessment method [13]
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Extended observation period. A disease relapse was defined as the occurrence of a serum alkaline phosphatase level that was \>= 80% of baseline serum alkaline phosphatase value.
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Timepoint [13]
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8 years was the maximum
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Secondary outcome [14]
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Number of Participants With Adverse Events
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Assessment method [14]
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Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
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Timepoint [14]
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147 months and 5 days
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Secondary outcome [15]
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Median Number of Cycles of Depsipeptide Administered
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Assessment method [15]
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Participants were administered Depsipeptide and cycles (each cycle is 21 days) were monitored from the prescribed dose or higher to determine reductions (if needed) to maintain tolerability.
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Timepoint [15]
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83 cycles (i.e., each cycle is 21 days)
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Secondary outcome [16]
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Time to Progression
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Assessment method [16]
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Time to progression is defined from the first day of therapy until documentation of progressive disease. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the International Working Group (IWG) criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry.
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Timepoint [16]
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Until disease progression, or 30 days following off study date
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Secondary outcome [17]
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Fold Change in Histone Acetylation
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Assessment method [17]
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Fold change is calculated by dividing the level of histone acetylation in a treated sample (at 4, 24, and 48 hours) measured as intensity on a dot blot immunoassay, divided by the intensity in the pre-treatment sample. We considered a = 2-fold change a measurable difference, and indicative of successful HDAC inhibition by romidepsin (depsipeptide).
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Timepoint [17]
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4 hours, 24 hours, and 48 hours after Romidepsin
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Secondary outcome [18]
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Multidrug Resistance Protein 1 (MDR1) or ATP-binding Cassette Sub-family B Member 1 (ABCB1) Gene Expression
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Assessment method [18]
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Total ribonucleic acid (RNA) was isolated from peripheral blood mononuclear cells or patient tissue biopsies and analyzed by quantitative polymerase chain reaction (qPCR). Expression of MDR-1/ABCB1 was determined by qPCR relative to an RNA standard, then normalized to ribosomal RNA (rRNA). Fold change is calculated by dividing the level of MDR-1 in a treated sample (at 4, 24, and 48 hours) measured by qPCR, divided by MDR-1 in the pre-treatment sample. We considered a = 2-fold change a measurable difference, and indicative of successful HDAC inhibition by romidepsin (depsipeptide).
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Timepoint [18]
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4 hours, 24 hours, and 48 hours after Romidepsin
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Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:
* Histologically proven melanoma of cutaneous origin or from unknown primary at initial presentation of primary or first clinically detected nodal or satellite/in-transit recurrence
* No distant metastases
* No melanoma of ocular, mucosal, or other non-cutaneous origin
* One of the following criteria must apply for patients with newly diagnosed melanoma OR a previously diagnosed primary with current subsequent, clinical, regional nodal disease and/or satellite/in-transit disease:
* Ulcerated primary melanoma with 1 or more involved lymph nodes (micro/occult or macro/clinically overt)
* Non-ulcerated or unknown primary melanoma with one macro/clinically overt lymph node metastasis, including a single matted nodal mass
* No non-ulcerated or unknown primary tumor and a single micrometastatic lymph node
* Non-ulcerated melanoma with two or more lymph node metastases (micro/occult or macro/clinically overt) and/or matted nodes
* Any satellite/in transit metastasis with or without lymph node involvement
* Patients with recurrent disease must have recurrent disease in the regional nodal basin of a prior complete lymphadenectomy
* Multiple regional nodal basin involvement allowed if they are appropriate anatomic drainage basins for primary site
* Patients must be disease free at time of enrollment based on the following surgical criteria:
* Patients at initial presentation of melanoma must undergo adequate wide excision of primary lesion
* Patients with previously diagnosed melanoma must have all disease resected with pathologically negative margins and no disease at primary site or second resection of primary
* Full lymphadenectomy required of all patients including those with positive sentinel nodes or positive satellite/in-transit metastasis
* No more than 56 days since prior lymphadenectomy OR surgery to remove recurrent disease after prior complete lymphadenectomy
* Must be willing to participate in minimal residual disease studies if registered on the study on 3/1/2003 or later
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Zubrod 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Absolute granulocyte count at least 1,500/mm^3
* Platelet count at least 100,000/mm^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT or SGPT no greater than 2 times ULN
* LDH and alkaline phosphatase no greater than 2 times ULN (above normal value requires a contrast-enhanced CT scan or MRI of liver)
* No known recent hepatitis positivity by PCR
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 75 mL/min
Cardiovascular:
* No congestive heart failure
* No coronary artery disease
* No serious cardiac arrhythmia
* No prior myocardial infarction
* Normal cardiac stress test required if any of the following are present:
* Over age 50
* Abnormal EKG
* History of cardiac disease
Pulmonary:
* No symptomatic pulmonary disease
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No autoimmune disorders or conditions of immunosuppression
* No other prior malignancy within the past 5 years except the following:
* Adequately treated basal cell or squamous cell skin cancer
* Carcinoma in situ of the cervix
* Adequately treated stage I or II cancer in remission
* HIV negative
* No known AIDS or HIV-1 associated complex
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior immunotherapy, including interferon, interleukin, levamisole, or other biologic response modifiers
* No other concurrent biologic therapy
Chemotherapy:
* No prior chemotherapy (including infusion or perfusion therapy)
* No other concurrent chemotherapy
Endocrine therapy:
* No concurrent systemic corticosteroids or topical steroid creams
* Concurrent steroid antihistamines allowed if no alternative
* No concurrent hormonal therapy
Radiotherapy:
* No prior radiotherapy
* Prior postlumpectomy radiotherapy for breast cancer allowed
* No concurrent radiotherapy
Surgery:
* See Disease Characteristics
* No concurrent surgery
Other:
* No concurrent anti-hypertensive medications (arm II only)
* No concurrent immunosuppressive agents
* No other concurrent anticancer therapy
* Antihistamines allowed if no alternative medication suitable
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2000
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2012
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Sample size
Target
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Accrual to date
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Final
432
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Recruitment in Australia
Recruitment state(s)
WA,NSW,VIC
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Recruitment hospital [1]
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0
Princess Margaret Hospital for Children - Perth
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Recruitment hospital [2]
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0
Sanofi-Aventis Administrative Office - Macquarie Park
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Recruitment hospital [3]
0
0
Westmead Institute for Cancer Research at Westmead Hospital - Westmead
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Recruitment hospital [4]
0
0
Novartis Investigative Site - Concord
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Recruitment hospital [5]
0
0
Novartis Investigative Site - Fitzroy
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Recruitment hospital [6]
0
0
Novartis Investigative site - Geelong
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Recruitment hospital [7]
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0
Novartis Investigative Site - Kogarah
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Recruitment hospital [8]
0
0
Novartis Investigative site - Maroochydore
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Recruitment hospital [9]
0
0
Novartis Investigative site - Nedlands
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Recruitment hospital [10]
0
0
Royal Children's Hospital - Parkville
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Recruitment hospital [11]
0
0
Royal Adelaide Hospital - Adelaide
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Recruitment hospital [12]
0
0
Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [13]
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0
Sir Charles Gairdner Hospital - Perth
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Recruitment postcode(s) [1]
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0
6001 - Perth
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Recruitment postcode(s) [2]
0
0
- Macquarie Park
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Recruitment postcode(s) [3]
0
0
2145 - Westmead
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Recruitment postcode(s) [4]
0
0
- Concord
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Recruitment postcode(s) [5]
0
0
- Fitzroy
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Recruitment postcode(s) [6]
0
0
- Geelong
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Recruitment postcode(s) [7]
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0
- Kogarah
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Recruitment postcode(s) [8]
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0
- Maroochydore
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Recruitment postcode(s) [9]
0
0
- Nedlands
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Recruitment postcode(s) [10]
0
0
3052 - Parkville
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Recruitment postcode(s) [11]
0
0
- Adelaide
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Recruitment postcode(s) [12]
0
0
- Melbourne
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Recruitment postcode(s) [13]
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0
- Perth
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arizona
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Arkansas
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Country [4]
0
0
United States of America
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State/province [4]
0
0
California
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Colorado
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Connecticut
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Delaware
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Country [8]
0
0
United States of America
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State/province [8]
0
0
District of Columbia
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Florida
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Georgia
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Idaho
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Country [12]
0
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United States of America
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Funding & Sponsors
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SWOG Cancer Research Network
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National Cancer Institute (NCI)
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Eastern Cooperative Oncology Group
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Cancer and Leukemia Group B
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Children's Oncology Group
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Ethics approval
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Summary
Brief summary
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known whether interferon alfa is more effective with or without combination chemotherapy and interleukin-2 for melanoma. PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without combination chemotherapy consisting of cisplatin, vinblastine, and dacarbazine, plus interleukin-2, in treating patients who have melanoma.
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Trial website
https://clinicaltrials.gov/study/NCT00546416
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Trial related presentations / publications
Flaherty LE, Othus M, Atkins MB, Tuthill RJ, Thompson JA, Vetto JT, Haluska FG, Pappo AS, Sosman JA, Redman BG, Moon J, Ribas A, Kirkwood JM, Sondak VK. Southwest Oncology Group S0008: a phase III trial of high-dose interferon Alfa-2b versus cisplatin, vinblastine, and dacarbazine, plus interleukin-2 and interferon in patients with high-risk melanoma--an intergroup study of cancer and leukemia Group B, Children's Oncology Group, Eastern Cooperative Oncology Group, and Southwest Oncology Group. J Clin Oncol. 2014 Nov 20;32(33):3771-8. doi: 10.1200/JCO.2013.53.1590. Epub 2014 Oct 20. Slamon D, Eiermann W, Robert N, Pienkowski T, Martin M, Press M, Mackey J, Glaspy J, Chan A, Pawlicki M, Pinter T, Valero V, Liu MC, Sauter G, von Minckwitz G, Visco F, Bee V, Buyse M, Bendahmane B, Tabah-Fisch I, Lindsay MA, Riva A, Crown J; Breast Cancer International Research Group. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011 Oct 6;365(14):1273-83. doi: 10.1056/NEJMoa0910383. Au HJ, Eiermann W, Robert NJ, Pienkowski T, Crown J, Martin M, Pawlicki M, Chan A, Mackey J, Glaspy J, Pinter T, Liu MC, Fornander T, Sehdev S, Ferrero JM, Bee V, Santana MJ, Miller DP, Lalla D, Slamon DJ; Translational Research in Oncology BCIRG 006 Trial Investigators. Health-related quality of life with adjuvant docetaxel- and trastuzumab-based regimens in patients with node-positive and high-risk node-negative, HER2-positive early breast cancer: results from the BCIRG 006 Study. Oncologist. 2013;18(7):812-8. doi: 10.1634/theoncologist.2013-0091. Epub 2013 Jun 28. Perez EA, Press MF, Dueck AC, Jenkins RB, Kim C, Chen B, Villalobos I, Paik S, Buyse M, Wiktor AE, Meyer R, Finnigan M, Zujewski J, Shing M, Stern HM, Lingle WL, Reinholz MM, Slamon DJ. Immunohistochemistry and fluorescence in situ hybridization assessment of HER2 in clinical trials of adjuvant therapy for breast cancer (NCCTG N9831, BCIRG 006, and BCIRG 005). Breast Cancer Res Treat. 2013 Feb;138(1):99-108. doi: 10.1007/s10549-013-2444-y. Epub 2013 Feb 19. Press MF, Sauter G, Buyse M, Bernstein L, Guzman R, Santiago A, Villalobos IE, Eiermann W, Pienkowski T, Martin M, Robert N, Crown J, Bee V, Taupin H, Flom KJ, Tabah-Fisch I, Pauletti G, Lindsay MA, Riva A, Slamon DJ. Alteration of topoisomerase II-alpha gene in human breast cancer: association with responsiveness to anthracycline-based chemotherapy. J Clin Oncol. 2011 Mar 1;29(7):859-67. doi: 10.1200/JCO.2009.27.5644. Epub 2010 Dec 28. Stern HM, Gardner H, Burzykowski T, Elatre W, O'Brien C, Lackner MR, Pestano GA, Santiago A, Villalobos I, Eiermann W, Pienkowski T, Martin M, Robert N, Crown J, Nuciforo P, Bee V, Mackey J, Slamon DJ, Press MF. PTEN Loss Is Associated with Worse Outcome in HER2-Amplified Breast Cancer Patients but Is Not Associated with Trastuzumab Resistance. Clin Cancer Res. 2015 May 1;21(9):2065-74. doi: 10.1158/1078-0432.CCR-14-2993. Epub 2015 Feb 3. Press MF, Sauter G, Buyse M, Fourmanoir H, Quinaux E, Tsao-Wei DD, Eiermann W, Robert N, Pienkowski T, Crown J, Martin M, Valero V, Mackey JR, Bee V, Ma Y, Villalobos I, Campeau A, Mirlacher M, Lindsay MA, Slamon DJ. HER2 Gene Amplification Testing by Fluorescent In Situ Hybridization (FISH): Comparison of the ASCO-College of American Pathologists Guidelines With FISH Scores Used for Enrollment in Breast Cancer International Research Group Clinical Trials. J Clin Oncol. 2016 Oct 10;34(29):3518-3528. doi: 10.1200/JCO.2016.66.6693. Widemann BC, Balis FM, Shalabi A, Boron M, O'Brien M, Cole DE, Jayaprakash N, Ivy P, Castle V, Muraszko K, Moertel CL, Trueworthy R, Hermann RC, Moussa A, Hinton S, Reaman G, Poplack D, Adamson PC. Treatment of accidental intrathecal methotrexate overdose with intrathecal carboxypeptidase G2. J Natl Cancer Inst. 2004 Oct 20;96(20):1557-9. doi: 10.1093/jnci/djh270. Widemann BC, Balis FM, Shalabi A, et al.: Carboxypeptidase-G2 (CPDG2) treatment of accidental intrathecal (IT) methotrexate (MTX) overdose. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-490, 2002. de Nigris F, Balestrieri ML, Napoli C. Targeting c-Myc, Ras and IGF cascade to treat cancer and vascular disorders. Cell Cycle. 2006 Aug;5(15):1621-8. doi: 10.4161/cc.5.15.3138. Epub 2006 Aug 1. Widemann BC, Arceci RJ, Jayaprakash N, Fox E, Zannikos P, Goodspeed W, Goodwin A, Wright JJ, Blaney SM, Adamson PC, Balis FM. Phase 1 trial and pharmacokinetic study of the farnesyl transferase inhibitor tipifarnib in children and adolescents with refractory leukemias: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2011 Feb;56(2):226-33. doi: 10.1002/pbc.22775. Epub 2010 Sep 21. Piekarz RL, Frye AR, Wright JJ, Steinberg SM, Liewehr DJ, Rosing DR, Sachdev V, Fojo T, Bates SE. Cardiac studies in patients treated with depsipeptide, FK228, in a phase II trial for T-cell lymphoma. Clin Cancer Res. 2006 Jun 15;12(12):3762-73. doi: 10.1158/1078-0432.CCR-05-2095. Woo S, Gardner ER, Chen X, Ockers SB, Baum CE, Sissung TM, Price DK, Frye R, Piekarz RL, Bates SE, Figg WD. Population pharmacokinetics of romidepsin in patients with cutaneous T-cell lymphoma and relapsed peripheral T-cell lymphoma. Clin Cancer Res. 2009 Feb 15;15(4):1496-503. doi: 10.1158/1078-0432.CCR-08-1215. Ritchie D, Piekarz RL, Blombery P, Karai LJ, Pittaluga S, Jaffe ES, Raffeld M, Janik JE, Prince HM, Bates SE. Reactivation of DNA viruses in association with histone deacetylase inhibitor therapy: a case series report. Haematologica. 2009 Nov;94(11):1618-22. doi: 10.3324/haematol.2009.008607. Epub 2009 Jul 16. Bates SE, Zhan Z, Steadman K, Obrzut T, Luchenko V, Frye R, Robey RW, Turner M, Gardner ER, Figg WD, Steinberg SM, Ling A, Fojo T, To KW, Piekarz RL. Laboratory correlates for a phase II trial of romidepsin in cutaneous and peripheral T-cell lymphoma. Br J Haematol. 2010 Jan;148(2):256-67. doi: 10.1111/j.1365-2141.2009.07954.x. Epub 2009 Oct 28. Akilov OE, Grant C, Frye R, Bates S, Piekarz R, Geskin LJ. Low-dose electron beam radiation and romidepsin therapy for symptomatic cutaneous T-cell lymphoma lesions. Br J Dermatol. 2012 Jul;167(1):194-7. doi: 10.1111/j.1365-2133.2012.10905.x. Noonan AM, Eisch RA, Liewehr DJ, Sissung TM, Venzon DJ, Flagg TP, Haigney MC, Steinberg SM, Figg WD, Piekarz RL, Bates SE. Electrocardiographic studies of romidepsin demonstrate its safety and identify a potential role for K(ATP) channel. Clin Cancer Res. 2013 Jun 1;19(11):3095-104. doi: 10.1158/1078-0432.CCR-13-0109. Epub 2013 Apr 15. Bates SE, Eisch R, Ling A, Rosing D, Turner M, Pittaluga S, Prince HM, Kirschbaum MH, Allen SL, Zain J, Geskin LJ, Joske D, Popplewell L, Cowen EW, Jaffe ES, Nichols J, Kennedy S, Steinberg SM, Liewehr DJ, Showe LC, Steakley C, Wright J, Fojo T, Litman T, Piekarz RL. Romidepsin in peripheral and cutaneous T-cell lymphoma: mechanistic implications from clinical and correlative data. Br J Haematol. 2015 Jul;170(1):96-109. doi: 10.1111/bjh.13400. Epub 2015 Apr 19. Piekarz RL, Frye R, Turner M, Wright JJ, Allen SL, Kirschbaum MH, Zain J, Prince HM, Leonard JP, Geskin LJ, Reeder C, Joske D, Figg WD, Gardner ER, Steinberg SM, Jaffe ES, Stetler-Stevenson M, Lade S, Fojo AT, Bates SE. Phase II multi-institutional trial of the histone deacetylase inhibitor romidepsin as monotherapy for patients with cutaneous T-cell lymphoma. J Clin Oncol. 2009 Nov 10;27(32):5410-7. doi: 10.1200/JCO.2008.21.6150. Epub 2009 Oct 13. Piekarz RL, Frye R, Prince HM, Kirschbaum MH, Zain J, Allen SL, Jaffe ES, Ling A, Turner M, Peer CJ, Figg WD, Steinberg SM, Smith S, Joske D, Lewis I, Hutchins L, Craig M, Fojo AT, Wright JJ, Bates SE. Phase 2 trial of romidepsin in patients with peripheral T-cell lymphoma. Blood. 2011 Jun 2;117(22):5827-34. doi: 10.1182/blood-2010-10-312603. Epub 2011 Feb 25. Shustov A, Coiffier B, Horwitz S, Sokol L, Pro B, Wolfson J, Balser B, Eisch R, Popplewell L, Prince HM, Allen SL, Piekarz R, Bates S. Romidepsin is effective and well tolerated in older patients with peripheral T-cell lymphoma: analysis of two phase II trials. Leuk Lymphoma. 2017 Oct;58(10):2335-2341. doi: 10.1080/10428194.2017.1295143. Epub 2017 Mar 7.
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Public notes
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Contacts
Principal investigator
Name
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Lawrence E. Flaherty, MD
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Address
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Barbara Ann Karmanos Cancer Institute
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Widemann BC, Balis FM, Shalabi A, Boron M, O'Brien...
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Widemann BC, Balis FM, Shalabi A, et al.: Carboxyp...
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Widemann BC, Arceci RJ, Jayaprakash N, Fox E, Zann...
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Bates SE, Eisch R, Ling A, Rosing D, Turner M, Pit...
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Piekarz RL, Frye R, Turner M, Wright JJ, Allen SL,...
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Piekarz RL, Frye R, Prince HM, Kirschbaum MH, Zain...
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Results are available at
https://clinicaltrials.gov/study/NCT00546416
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