Brain and Central Nervous System Tumors Clinical Trial
Official title:
A TRIAL OF INTENSIVE CHEMOTHERAPY AND AUTOLOGOUS STEM CELL RECONSTITUTION FOR PATIENTS BETWEEN SIX AND SIXTY YEARS OF AGE, WITH NON-PROGRESSIVE GLIOBLASTOMA MULTIFORME OR DIFFUSE INTRINSIC BRAINSTEM TUMORS, FOLLOWING INITIAL LOCAL-FIELD IRRADIATION
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.
OBJECTIVES: I. Estimate the overall survival, progression-free interval, and time to
progression or recurrence in patients with nondisseminated glioblastoma multiforme or
diffuse intrinsic brain stem tumors that are nonprogressive following surgery (if feasible)
and involved-field irradiation and treated with intensive chemotherapy followed by
autologous peripheral blood stem cell (PBSC) or autologous bone marrow (ABM) rescue. II.
Estimate the toxicity of myeloablative chemotherapy with thiotepa (TSPA) followed by
carboplatin (CBDCA) in these patients. III. Evaluate the pharmacokinetic interactions of
high-dose CBDCA, TSPA, and triethylenephosphoramide (a metabolite of TSPA) and any impact on
subsequent toxicity. IV. Evaluate the effectiveness of autologous stem cells in restoring
hematopoiesis following myeloablative therapy.
OUTLINE: All patients undergo bone marrow or stem cell harvest (investigator option) no
later than 12 weeks after completion of radiotherapy. The following acronyms are used: ABM
Autologous Bone Marrow CBDCA Carboplatin, NSC-241240 G-CSF Granulocyte Colony-Stimulating
Factor (Amgen), NSC-614629 PBSC Peripheral Blood Stem Cells TSPA Thiotepa, NSC-6396 2-Drug
Myeloablative Chemotherapy followed by Hematopoietic Rescue. TSPA; CBDCA; followed by ABM or
PBSC; G-CSF.
PROJECTED ACCRUAL: 60 patients will be entered over 3 years. If more than 5 patients on any
arm experience treatment-related mortality, accrual will be discontinued.
;
Primary Purpose: Treatment
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