Radiation Therapy, Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Primitive Neuroectodermal Tumors
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|ClinicalTrials.gov Identifier: NCT00003846|
Recruitment Status : Completed
First Posted : May 25, 2004
Last Update Posted : July 28, 2014
RATIONALE: Radiation therapy uses x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of radiation therapy and chemotherapy and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy, chemotherapy and peripheral stem cell transplantation in treating patients with primitive neuroectodermal tumors.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors Neuroblastoma||Biological: filgrastim Drug: carboplatin Drug: cyclophosphamide Drug: thiotepa Drug: vincristine sulfate Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy||Phase 2|
- Determine the safety of postradiotherapy high-dose consolidation chemotherapy with peripheral blood stem cell (PBSC) support in patients with high-risk primitive neuroectodermal tumors.
- Determine the safety of delaying radiotherapy by approximately one month in these patients.
- Determine the maximum tolerated dose of thiotepa in these patients.
- Determine the toxic effects of intensive chemotherapy with PBSC support in these patients.
- Assess the time to hematopoietic recovery after PBSC infusion when intensive chemotherapy is used after craniospinal radiotherapy in these patients.
- Determine the overall and event-free survival of patients treated with this regimen.
OUTLINE: This is a dose-escalation study of thiotepa during consolidation therapy.
- Induction: Within 31 days of initial surgery, patients receive induction therapy comprising vincristine IV on day 0, cyclophosphamide IV over 2 hours on days 0 and 1, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 2 and continuing for at least 7-10 days. Peripheral blood stem cells (PBSC) are then collected.
- Chemoradiotherapy: After blood cell counts recover, and within 28 days of starting induction, patients begin chemoradiotherapy. Patients receive vincristine IV once weekly for 8 doses. Radiotherapy is administered 5 days a week, for 6 weeks, beginning within the same week as the start of vincristine.
- Consolidation: Therapy begins 4-6 weeks after the last radiation treatment in the absence of disease progression. The first and third course are the same and comprise vincristine IV on day 0, carboplatin IV over 1 hour on days 0 and 1, thiotepa IV over 3 hours on days 2-4, and G-CSF SC daily beginning on day 7. PBSC are reinfused on day 7. The second course comprises vincristine IV on day 0, carboplatin IV over 1 hour on days 0 and 1, cyclophosphamide IV over 2 hours on days 2 and 3, and G-CSF SC daily beginning on day 5. PBSC are reinfused on day 5. Each course lasts 21 days.
For consolidation therapy, cohorts of 6-12 patients each receive escalating doses of thiotepa until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 12 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 24-56 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of High Risk Central Nervous System Embryonal Tumors With Conventional Radiotherapy and Intensive Consolidation Chemotherapy With Peripheral Blood Progenitor Cell (PBSC) Support|
|Study Start Date :||July 1999|
|Actual Primary Completion Date :||October 2004|
|Actual Study Completion Date :||March 2007|
See detailed description.
Drug: vincristine sulfate
Procedure: bone marrow ablation with stem cell support
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
- Event Free Survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003846
|United States, California|
|Children's Hospital Los Angeles|
|Los Angeles, California, United States, 90027-0700|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|Children's Hospital of Orange County|
|Orange, California, United States, 92668|
|United States, Colorado|
|Children's Hospital of Denver|
|Denver, Colorado, United States, 80218|
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20010-2970|
|United States, Minnesota|
|University of Minnesota Cancer Center|
|Minneapolis, Minnesota, United States, 55455|
|United States, New York|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center|
|New York, New York, United States, 10016|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Ohio|
|Children's Hospital Medical Center - Cincinnati|
|Cincinnati, Ohio, United States, 45229-3039|
|Children's Hospital of Columbus|
|Columbus, Ohio, United States, 43205-2696|
|United States, Oregon|
|Oregon Cancer Center at Oregon Health Sciences University|
|Portland, Oregon, United States, 97201-3098|
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109|
|Study Chair:||H. Stacy Nicholson, MD, MPH||OHSU Knight Cancer Institute|