Overview

Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Glioblastoma Multiforme or Brain Stem Tumors

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bone marrow or peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by autologous bone marrow or peripheral stem cell transplantation in treating patients with glioblastoma multiforme or brain stem tumors.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
New York University School of Medicine
NYU Langone Health
Treatments:
Carboplatin
Thiotepa
Criteria
DISEASE CHARACTERISTICS: Glioblastoma multiforme (GBM) or brain stem tumor following
surgery (if feasible) and local radiotherapy, as follows: Pathologically confirmed primary
GBM Gliosarcomas and multifocal GBM eligible Unbiopsied diffuse intrinsic pontine tumors
Nonenhancing with gadolinium on MRI T1 hypodense and T2 hyperdense No recurrent or
progressing disease following radiotherapy No leptomeningeal dissemination by radiographic
evaluation including head MRI and either whole-spine MRI with gadolinium or myelogram
Positive CSF cytology alone allowed No extraneural metastases

PATIENT CHARACTERISTICS: Age: 6 to under 60 Performance status: Karnofsky 70%-100% (over
age 16) Lansky 70%-100% (ages 6-16) Hematopoietic: Not specified Hepatic: Bilirubin less
than 2.0 mg/dL AST or ALT less than 5 times normal PT and aPTT normal (consult with
principal investigator if abnormal) Renal: Creatinine clearance at least 50 mL/min/1.73 sqm
Cardiovascular: No evidence of myocardial infarction or ischemia on EKG Other: No active
infection at time of leukapheresis Able to tolerate anticoagulation

PRIOR CONCURRENT THERAPY: Radical surgery and involved-field radiotherapy (at least 4,500
cGy) completed within 6 weeks prior to entry Second surgical debulking following
radiotherapy strongly encouraged for patients with residual tumor mass or suspected
radionecrosis Requirement for surgery waived for unresectable brainstem tumors No prior
chemotherapy except corticosteroids