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A Pilot Study of Intensive Chemotherapy With Peripheral Stem Cell Support for Infants With Malignant Brain Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctors to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating infants with malignant brain or spinal cord tumors.
OBJECTIVES: * Determine the maximum tolerated dose of thiotepa in infants with malignant brain or spinal cord tumors receiving intensive chemotherapy. * Determine the feasibility and toxicity of intensive chemotherapy with peripheral blood stem cell (PBSC) rescue in these patients. * Assess the feasibility of harvesting PBSCs in these patients. * Determine the complete response rate and overall event-free survival rate in patients treated with this regimen. OUTLINE: This is a pilot, multicenter study. Patients undergo surgery for diagnosis and maximal tumor resection. Within 6 weeks of surgery or when stable, patients begin induction chemotherapy comprising cisplatin IV over 6 hours on day 0; vincristine IV on days 0, 7, and 14; cyclophosphamide IV over 1 hour on days 1-2; and etoposide IV over 1 hour on days 0-2. Twenty four hours after the last cyclophosphamide dose, patients receive filgrastim (G-CSF) subcutaneously (SC) and undergo peripheral blood stem cell harvest 2 days later. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Within 6 weeks after induction chemotherapy, patients receive consolidation chemotherapy comprising carboplatin IV over 2 hours on days 0-1 followed immediately by escalating doses of thiotepa IV over 2 hours. Patients then undergo peripheral blood stem cell transplantation 48 hours after the last thiotepa dose. Patients receive G-CSF SC daily on days 3 to 21. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing dose-limiting toxicity due to thiotepa are removed from the study. Patients are followed at 4 weeks, every 3 months for 1 year, every 6 months for 3 years, and then annually for 3 years or until relapse. PROJECTED ACCRUAL: A total of 83 patients will be accrued for this study within 1 year.
Age
0 - 2 years
Sex
ALL
Healthy Volunteers
No
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Childrens Hospital Los Angeles
Los Angeles, California, United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Children's Hospital Central California
Madera, California, United States
Children's Hospital and Research Center Oakland
Oakland, California, United States
Children's Hospital of Orange County
Orange, California, United States
Kaiser Permanente Medical Center - Oakland
Sacramento, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Children's Hospital Center for Cancer and Blood Disorders
Aurora, Colorado, United States
Start Date
March 1, 1998
Primary Completion Date
December 1, 2007
Completion Date
October 1, 2011
Last Updated
March 28, 2014
94
ACTUAL participants
filgrastim
BIOLOGICAL
carboplatin
DRUG
cisplatin
DRUG
cyclophosphamide
DRUG
etoposide
DRUG
thiotepa
DRUG
vincristine sulfate
DRUG
conventional surgery
PROCEDURE
peripheral blood stem cell transplantation
PROCEDURE
Lead Sponsor
Children's Oncology Group
Collaborators
NCT04936529
NCT06541262
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT04851119