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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00070200
Registration number
NCT00070200
Ethics application status
Date submitted
3/10/2003
Date registered
7/10/2003
Date last updated
13/02/2014
Titles & IDs
Public title
Induction Chemotherapy Using Cyclophosphamide and Topotecan in Treating Patients Who Are Undergoing Autologous Peripheral Stem Cell Transplantation for Newly Diagnosed or Progressive Neuroblastoma
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Scientific title
A Pilot Induction Regimen Incorporating Topotecan for Treatment of Newly Diagnosed High Risk Neuroblastoma
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Secondary ID [1]
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CDR0000330140
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Secondary ID [2]
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ANBL02P1
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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:
Neuroblastoma
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Condition category
Condition code
Cancer
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Neuroendocrine tumour (NET)
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Cancer
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Children's - Other
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - filgrastim
Treatment: Drugs - cisplatin
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - doxorubicin hydrochloride
Treatment: Drugs - etoposide
Treatment: Drugs - isotretinoin
Treatment: Drugs - melphalan
Treatment: Drugs - topotecan hydrochloride
Treatment: Drugs - vincristine sulfate
Treatment: Surgery - conventional surgery
Treatment: Surgery - peripheral blood stem cell transplantation
Treatment: Other - radiation therapy
Experimental: All patients - Induction Cycles 1 and 2 (CT) (21 days each), Cyclophosphamide (Days 1 thru 5) weight based dosage (> 12 kg 400 mg/m2/day, < 12 kg 13.3 mg/kg/day, < 2 years old N/A. Topotecan (Days 1 thru 5) weight based dosage (> 12 kg 1.2 mg/m2/day, < 12 kg 0.04 mg/kg/day, < 2 years old 0.04 mg/kg/day). Filgrastim (Days 6 ?) weight based dosage (> 12 kg 5 micrograms/kg, < 12 kg 5 micrograms /kg, < 2 years old 5 micrograms /kg.
Other interventions: filgrastim
Treatment: Drugs: cisplatin
Treatment: Drugs: cyclophosphamide
Treatment: Drugs: doxorubicin hydrochloride
Treatment: Drugs: etoposide
Treatment: Drugs: isotretinoin
Treatment: Drugs: melphalan
Treatment: Drugs: topotecan hydrochloride
Treatment: Drugs: vincristine sulfate
Treatment: Surgery: conventional surgery
Treatment: Surgery: peripheral blood stem cell transplantation
Treatment: Other: radiation therapy
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Intervention code [3]
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Treatment: Surgery
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Intervention code [4]
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Treatment: Other
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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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Proportion of patients who are classified as a "success"
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Assessment method [1]
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Given that the documented delivered dose intensity of chemotherapy in current induction regimens is 75-85% of the intended dose intensity,5,78 we shall consider an individual patient as a "success" in terms of feasibility if the patient is able to receive 75% or more of the intended chemotherapy doses of known active agents.
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Timepoint [1]
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Length of study
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Secondary outcome [1]
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Number of toxic deaths
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Assessment method [1]
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Timepoint [1]
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Length of study
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Secondary outcome [2]
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Proportion of patients with dose limiting toxicities during induction cycle 1 and 2
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Assessment method [2]
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Dose limiting toxicities during induction cycle 1 and 2 will be used to modify the topotecan dosage if necessary and to address Primary Aim 1 in a descriptive fashion.
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Timepoint [2]
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Length of study
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Secondary outcome [3]
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Tumor contamination of PBSCs
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Assessment method [3]
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Tumor contamination of PBSCs as measured by immunohistochemical analysis following cycle 2 induction;
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Timepoint [3]
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Length of study
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Secondary outcome [4]
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Inability to adequately mobilize PBSCs
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Assessment method [4]
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Inability to adequately mobilize PBSCs, defined as a harvest of < 1.5 x 10 6 CD 34 cells/kg. A patient will be designated a PBSCs "failure" if either a) or b) is the case.
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Timepoint [4]
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Length of study
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Secondary outcome [5]
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Assessment of response
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Assessment method [5]
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After completion of induction therapy. Response will be determined using the International Response Criteria defined elsewhere in the protocol. The tumor response rate will be defined as the proportion of patients who achieve a CR, VGPR, or PR after completion of induction therapy.
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Timepoint [5]
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Length of study
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Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed neuroblastoma or ganglioneuroblastoma
meeting 1 of the following staging criteria:
- Newly diagnosed disease, at least 1 year of age, and meets criteria for 1 of the
following:
- International Neuroblastoma Staging System (INSS) stage 2a/2b with MYCN
amplification (greater than 10) AND unfavorable pathology
- INSS stage 3 with MYCN amplification OR unfavorable pathology
- Newly diagnosed INSS stage 4 disease meeting criteria for 1 of the following:
- Over 18 months of age
- Age 12 to 18 months with any unfavorable biologic feature (MYCN
amplification, unfavorable pathology, and/or DNA index=1) or any biologic
feature that is indeterminant, unsatisfactory, or unknown
- No INSS stage 4 disease and age 12 to 18 months with all 3 favorable
biologic features (i.e., nonamplified MYCN, favorable pathology, and
DNA index greater than 1)
- Newly diagnosed INSS stage 3, 4, or 4S disease AND under 1 year of age with MYCN
amplification
- At least 1 year of age and initially diagnosed with INSS stage 1, 2, or 4S
disease that progressed to stage 4 without interval chemotherapy
- Must have been enrolled on COG-ANBL00B1 at initial diagnosis
PATIENT CHARACTERISTICS:
Age
- 30 and under at initial diagnosis
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,000/mm^3*
- Platelet count at least 100,000/mm^3* (transfusion independent)
- Hemoglobin at least 10.0 g/dL* (red blood cell transfusions allowed) NOTE:
*Granulocytopenia, anemia, and/or thrombocytopenia allowed for patients with tumor
metastatic to the bone marrow
Hepatic
- Bilirubin no greater than 1.5 mg/dL
- ALT less than 300 IU/L
Renal
- Creatinine no greater than 1.5 mg/dL
- Creatinine clearance or radioisotope glomerular filtration rate at least 60 mL/min
Cardiovascular
- ECG normal
- Shortening fraction at least 27% by echocardiogram OR
- Ejection fraction at least 50% by MUGA
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- No more than 1 prior chemotherapy course on the low- or intermediate-risk
neuroblastoma studies (COG-P9641, COG-A3961) prior to determination of MYCN
amplification and Shimada histology
Endocrine therapy
- Not specified
Radiotherapy
- Prior localized emergency radiotherapy to sites of life-threatening or
function-threatening disease allowed
Surgery
- Not specified
Other
- No other prior systemic therapy
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Minimum age
No limit
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Maximum age
30
Years
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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
N/A
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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
Single group
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Other design features
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Phase
Phase 1
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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
1/03/2004
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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
1/12/2013
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Sample size
Target
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Accrual to date
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Final
31
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Westmead Hospital - Westmead
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment outside Australia
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Illinois
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United States of America
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State/province [3]
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Tennessee
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United States of America
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State/province [4]
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Washington
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Address
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Other collaborator category [1]
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Government body
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Name [1]
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National Cancer Institute (NCI)
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
RATIONALE: Drugs used in chemotherapy, such as topotecan and cyclophosphamide, use different
ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy
with autologous stem cell transplantation may allow the doctor to give higher doses of
chemotherapy drugs and kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects of induction chemotherapy using
cyclophosphamide and topotecan in treating patients who are undergoing surgery and autologous
stem cell transplantation followed by radiation therapy for newly diagnosed or progressive
neuroblastoma.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00070200
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Julie R. Park, MD
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Address
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Seattle Children's Hospital
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00070200
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