Combination Chemotherapy Plus Peripheral Stem Cell Transplantation Followed by Surgery and/or Radiation Therapy in Treating Young Patients With Advanced Neuroblastoma
NCT ID: NCT00002740
Last Updated: 2014-07-24
Study Results
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Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
1996-05-31
2005-09-30
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation followed by surgery and/or radiation therapy in treating young patients who have newly diagnosed advanced neuroblastoma.
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Detailed Description
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OUTLINE: This is a dose escalation study of carboplatin. Patients receive induction chemotherapy consisting of vincristine IV over 24 hours, cyclophosphamide IV over 4 hours, and doxorubicin IV over 24 hours on days 0, 1, 21, and 22. Patients receive filgrastim (G-CSF) subcutaneously (SQ) or IV beginning on days 3 and 24 and continuing until blood counts recover. Patients undergo peripheral blood stem cell (PBSC) collection after course 2 of induction chemotherapy. Patients receive G-CSF SQ or IV for 2 days prior to and during collection. PBSC are collected daily for 1-3 days. Patients may undergo autologous bone marrow collection after course 1 of consolidation therapy (after PBSC collection). Following mobilization, patients receive consolidation chemotherapy consisting of etoposide IV over 4 hours on days 0, 1, and 2 and carboplatin IV over 1 hour and cyclophosphamide IV over 4 hours on days 0 and 1. Patients receive G-CSF SQ or IV beginning on day 3 (within 4 hours of PBSC infusion) and continuing until blood counts recover. Patients receive PBSC reinfusion at 48-72 hours following completion of each chemotherapy course. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Upon recovery from consolidation chemotherapy, patients with no disease progression undergo tumor resection with or without radiotherapy. Patients undergoing radiotherapy receive therapy twice daily over 7 days. Patients with no disease progression, less than 2% detectable bone marrow disease, and adequate bone marrow cellularity may undergo additional therapy consisting of autologous bone marrow transplantation per appropriate transplant protocol. Cohorts of 6-12 patients receive escalating doses of carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 or 4 of 12 patients experience dose limiting toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 24-30 patients will be accrued for this study within approximately 2 years.
Conditions
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Study Design
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TREATMENT
Study Groups
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Treatment - Carboplatin Chemotherapy
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filgrastim
carboplatin
cyclophosphamide
doxorubicin hydrochloride
etoposide
mesna
vincristine sulfate
conventional surgery
peripheral blood stem cell transplantation
low-LET cobalt-60 gamma ray therapy
low-LET photon therapy
Interventions
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filgrastim
carboplatin
cyclophosphamide
doxorubicin hydrochloride
etoposide
mesna
vincristine sulfate
conventional surgery
peripheral blood stem cell transplantation
low-LET cobalt-60 gamma ray therapy
low-LET photon therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 1 to 21 Performance status: Not specified Hematopoietic: (unless bone marrow involvement by tumor) Absolute neutrophil count greater than 1,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 3.0 mg/dL Renal: Creatinine less than 1.5 mg/dL Creatinine clearance or radionuclide GFR greater than 60 mL/min Cardiovascular: EKG normal Ejection fraction at least 55% by radionuclide MUGA OR Fractional shortening at least 28% by echocardiogram Other: No other significant organ dysfunction that precludes study treatment Body weight at least 10 kg Not pregnant or nursing Effective contraception required of fertile patients
PRIOR CONCURRENT THERAPY: No prior systemic chemotherapy No prior radiotherapy except as emergency treatment
1 Year
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Susan G. Kreissman, MD
Role: STUDY_CHAIR
Duke Cancer Institute
Locations
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Children's Hospital Los Angeles
Los Angeles, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, United States
Children's Hospital of Columbus
Columbus, Ohio, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States
Countries
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References
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Bensimhon P, Villablanca JG, Sender LS, Matthay KK, Park JR, Seeger R, London WB, Yap JS, Kreissman SG. Peripheral blood stem cell support for multiple cycles of dose intensive induction therapy is feasible with little risk of tumor contamination in advanced stage neuroblastoma: a report from the Childrens Oncology Group. Pediatr Blood Cancer. 2010 Apr;54(4):596-602. doi: 10.1002/pbc.22344.
Other Identifiers
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CCG-3951
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000064656
Identifier Type: OTHER
Identifier Source: secondary_id
3951
Identifier Type: -
Identifier Source: org_study_id
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