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

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

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 autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Isotretinoin may be effective in preventing recurrence of glioma. It is not yet known which regimen of chemotherapy plus autologous stem cell transplantation with or without isotretinoin is more effective in treating recurrent high-grade glioma.

PURPOSE: This randomized phase III trial is studying high-dose chemotherapy or intermediate-dose chemotherapy followed by autologous stem cell transplantation to see how well it works compared to high-dose chemotherapy or intermediate-dose chemotherapy followed by autologous stem cell transplantation and isotretinoin in treating young patients with recurrent high-grade glioma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Etoposide; Etoposide phosphate; Isotretinoin; Lenograstim; Sargramostim; Thiotepa

Criteria

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