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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


Phase 2
6 Years
59 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Jonathan L. Finlay, MB, ChB

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine

Authority:

United States: Federal Government

Study ID:

CDR0000063964

NCT ID:

NCT00002619

Start Date:

September 1994

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult brain stem glioma
  • adult glioblastoma
  • childhood high-grade cerebral astrocytoma
  • untreated childhood brain stem glioma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Brain Stem Neoplasms

Name

Location
Kaplan Cancer Center New York, New York  10016