Status:
COMPLETED
High-Dose Chemotherapy Plus Autologous Stem Cell Transplantation Compared With Intermediate-Dose Chemotherapy Plus Autologous Stem Cell Transplantation With or Without Isotretinoin in Treating Young Patients With Recurrent High-Grade Gliomas
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain Tumor
Central Nervous System Tumor
Eligibility:
All Genders
Up to 20 years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin, thiotepa, and etoposide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with a...
Detailed Description
OBJECTIVES: * Compare the event-free survival and overall survival of pediatric patients with recurrent high-grade gliomas treated with a single course of high-dose carboplatin, etoposide, and thiote...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of 1 of the following high-grade gliomas:
- Glioblastoma multiforme
- Anaplastic astrocytoma
- Gliosarcoma
- Disease in first relapse
- No primary brainstem or spinal cord gliomas
- No secondary glioblastomas arising after prior treatment for a non-glial tumor
- Prior local radiotherapy of 5,000-6,000 cGy required
- Less than 1.5 cm of residual gadolinium-enhancing tumor in maximal cross-sectional diameter by MRI
- No metastatic tumor by spinal MRI
- PATIENT CHARACTERISTICS:
- Age
- Under 21 at diagnosis
- Performance status
- Lansky 50-100% OR
- Karnofsky 50-100%
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 500/mm\^3
- Platelet count ≥ 100,000/mm\^3 (transfusion independent)
- Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST or ALT \< 2.5 times ULN
- Renal
- Glomerular filtration rate ≥ 60 mL/min AND/OR
- Creatinine clearance ≥ 60 mL/min
- Cardiovascular
- Shortening fraction ≥ 27% by echocardiogram OR
- Ejection fraction ≥ 50% by MUGA
- Pulmonary
- No dyspnea at rest
- No exercise intolerance
- Pulse oximetry \> 94%
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- More than 4 weeks since prior chemotherapy
- No prior thiotepa
- No prior myeloablative chemotherapy
- Endocrine therapy
- No concurrent corticosteroids
- Radiotherapy
- See Disease Characteristics
- More than 8 weeks since prior radiotherapy
- No prior craniospinal radiotherapy
- Surgery
- Not specified
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00078988
Start Date
October 1 2004
End Date
September 1 2006
Last Update
May 7 2015
Active Locations (59)
Enter a location and click search to find clinical trials sorted by distance.
1
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
Children's Hospital and Research Center - Oakland
Oakland, California, United States, 94609-1809
3
University of California Davis Cancer Center
Sacramento, California, United States, 95817
4
Children's Hospital and Health Center - San Diego
San Diego, California, United States, 92123-4282