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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00002619
First received: November 1, 1999
Last updated: November 8, 2012
Last verified: June 2000
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Biological: filgrastim
Drug: carboplatin
Drug: thiotepa
Procedure: autologous bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Estimated Enrollment: 60
Study Start Date: September 1994
Primary Completion Date: April 2000 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002619

Locations
United States, New York
Kaplan Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Study Chair: Jonathan L. Finlay, MB, ChB New York University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00002619     History of Changes
Other Study ID Numbers: CDR0000063964, NYU-97-8, MSKCC-94101, NCI-V94-0594
Study First Received: November 1, 1999
Last Updated: November 8, 2012
Health Authority: United States: Federal Government

Keywords provided by New York University School of Medicine:
adult brain stem glioma
adult glioblastoma
childhood high-grade cerebral astrocytoma
untreated childhood brain stem glioma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Glioblastoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Brain Stem Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Infratentorial Neoplasms
Brain Neoplasms
Brain Diseases
Central Nervous System Diseases
Thiotepa
Carboplatin
Lenograstim
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Immunosuppressive Agents

ClinicalTrials.gov processed this record on April 17, 2014