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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/NCT00017368
Registration number
NCT00017368
Ethics application status
Date submitted
6/06/2001
Date registered
9/10/2003
Date last updated
13/02/2014
Titles & IDs
Public title
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Neuroblastoma
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Scientific title
A Pilot Study Of Tandem High Dose Chemotherapy With Stem Cell Rescue Following Induction Therapy In Children With High Risk Neuroblastoma
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Secondary ID [1]
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COG-ANBL00P1
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Secondary ID [2]
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ANBL00P1
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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
Other interventions - sargramostim
Treatment: Drugs - carboplatin
Treatment: Drugs - cisplatin
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - doxorubicin hydrochloride
Treatment: Drugs - etoposide
Treatment: Drugs - etoposide phosphate
Treatment: Drugs - ifosfamide
Treatment: Drugs - isotretinoin
Treatment: Drugs - melphalan
Treatment: Drugs - thiotepa
Treatment: Drugs - vincristine sulfate
Treatment: Surgery - conventional surgery
Treatment: Surgery - peripheral blood stem cell transplantation
Treatment: Other - radiation therapy
Experimental: All Patients -
Other interventions: filgrastim
Other interventions: sargramostim
Treatment: Drugs: carboplatin
Treatment: Drugs: cisplatin
Treatment: Drugs: cyclophosphamide
Treatment: Drugs: doxorubicin hydrochloride
Treatment: Drugs: etoposide
Treatment: Drugs: etoposide phosphate
Treatment: Drugs: ifosfamide
Treatment: Drugs: isotretinoin
Treatment: Drugs: melphalan
Treatment: Drugs: thiotepa
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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Transplant-related mortality
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Assessment method [1]
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The endpoint used for early stopping rule 9.51 will be transplant-related mortality (TRM). A TRM is defined as any death occurring within 30 days after either the first or second HDC/SCR. The acceptable TRM rate is 7.5%. This rate is based on TRM rates previously observed in the prior CCG study 594, CCG study 3891, and POG study 9640 of 7%, 6%, and 0%, respectively.
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Timepoint [1]
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Secondary outcome [1]
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Incidence of symptomatic CMV, disseminated adenovirus infection, or EBV-LPD
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Assessment method [1]
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The endpoint to be used in assessing early stopping rule 9.52 will be the incidence of symptomatic CMV, disseminated adenovirus infection, or EBV-LPD. Patients with positive CMV antigenemia or CMV urine culture only (without symptoms of CMV infection), or patients who have a positive culture for adenovirus without evidence of dissemination, or patients with a positive EBV PCR who do not exhibit significant clinical signs (such as adenopathy) or symptoms will not trigger the stopping rule.
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Timepoint [1]
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Secondary outcome [2]
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Event-free Survival
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Assessment method [2]
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Assessment of feasibility and toxicity at the end of the study is time to event. Time to event is defined as the time from registration on the study until the first of the following events occurs: relapse, progression, secondary malignancy, or death, including toxic death. If none of those events occurs, then the time of last contact with the patient is used. Time to event will be used to calculate the one-year Event-free Survival (EFS) rate.
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Timepoint [2]
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1 year
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Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:
- Newly diagnosed high-risk neuroblastoma
- Histologically proven AND/OR
- Bone marrow specimen showing clumps of tumor cells accompanied by elevated
urinary catecholamines
- Age 1-30:
- Must meet one of the following INSS staging criteria:
- Stage IV regardless of biologic factors
- Stage IIa/IIb with MYCN oncogene amplification (greater than 10) and
unfavorable pathology
- Stage III with MYCN oncogene amplification (greater than 10) or
unfavorable pathology
- Initially stage I, II, or IVS, that has progressed without interval
chemotherapy
- Under age 1:
- INSS stage III, IV, or IVS with MYCN amplification (greater than 10)
- Must enter neuroblastoma biology study COG-ANBL00B1 within 2 weeks of diagnosis and
before entry on this study
PATIENT CHARACTERISTICS:
Age:
- 30 and under at original diagnosis
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- No more than 1 prior course of chemotherapy on the intergroup low- or
intermediate-risk neuroblastoma studies prior to determination of MYCN status and
Shimada histology
Endocrine therapy:
- Not specified
Radiotherapy:
- Prior emergent radiotherapy to sites of function- or life-threatening neuroblastoma
allowed
Surgery:
- Not specified
Other:
- No other prior systemic therapy for neuroblastoma
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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 2
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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
1/04/2001
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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
1/01/2012
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Sample size
Target
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Accrual to date
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Final
42
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Princess Margaret Hospital for Children - Perth
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Recruitment postcode(s) [1]
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6001 - Perth
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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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Georgia
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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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Massachusetts
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United States of America
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State/province [3]
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Oregon
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Country [4]
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United States of America
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State/province [4]
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Pennsylvania
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Country [5]
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United States of America
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State/province [5]
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Texas
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Country [6]
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United States of America
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State/province [6]
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Wisconsin
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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 use different ways to stop tumor cells from dividing so
they stop growing or die. Combining more than one drug may kill more tumor cells. Peripheral
stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and
kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by
peripheral stem cell transplantation in treating children who have newly diagnosed
neuroblastoma.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00017368
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Trial related presentations / publications
Marcus KJ, Shamberger R, Litman H, von Allmen D, Grupp SA, Nancarrow CM, Goldwein J, Grier HE, Diller L. Primary tumor control in patients with stage 3/4 unfavorable neuroblastoma treated with tandem double autologous stem cell transplants. J Pediatr Hematol Oncol. 2003 Dec;25(12):934-40. doi: 10.1097/00043426-200312000-00005.
Kletzel M, Katzenstein HM, Haut PR, Yu AL, Morgan E, Reynolds M, Geissler G, Marymount MH, Liu D, Kalapurakal JA, Shore RM, Bardo DM, Schmoldt J, Rademaker AW, Cohn SL. Treatment of high-risk neuroblastoma with triple-tandem high-dose therapy and stem-cell rescue: results of the Chicago Pilot II Study. J Clin Oncol. 2002 May 1;20(9):2284-92. doi: 10.1200/JCO.2002.06.060.
Donovan J, Temel J, Zuckerman A, Gribben J, Fang J, Pierson G, Ross A, Diller L, Grupp SA. CD34 selection as a stem cell purging strategy for neuroblastoma: preclinical and clinical studies. Med Pediatr Oncol. 2000 Dec;35(6):677-82. doi: 10.1002/1096-911x(20001201)35:63.0.co;2-h.
Grupp SA, Stern JW, Bunin N, Nancarrow C, Adams R, Gorlin JB, Griffin G, Diller L. Rapid-sequence tandem transplant for children with high-risk neuroblastoma. Med Pediatr Oncol. 2000 Dec;35(6):696-700. doi: 10.1002/1096-911x(20001201)35:63.0.co;2-0.
Grupp SA, Stern JW, Bunin N, Nancarrow C, Ross AA, Mogul M, Adams R, Grier HE, Gorlin JB, Shamberger R, Marcus K, Neuberg D, Weinstein HJ, Diller L. Tandem high-dose therapy in rapid sequence for children with high-risk neuroblastoma. J Clin Oncol. 2000 Jul;18(13):2567-75. doi: 10.1200/JCO.2000.18.13.2567.
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Public notes
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Contacts
Principal investigator
Name
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Stephan A. Grupp, MD, PhD
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Address
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Children's Hospital of Philadelphia
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Fax
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00017368
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