NCT00002619

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1994

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2000

Completed
4.4 years until next milestone

First Posted

Study publicly available on registry

August 11, 2004

Completed
Last Updated

November 9, 2012

Status Verified

June 1, 2000

Enrollment Period

5.6 years

First QC Date

November 1, 1999

Last Update Submit

November 8, 2012

Conditions

Brain and Central Nervous System Tumors

Keywords

adult brain stem gliomaadult glioblastomachildhood high-grade cerebral astrocytomauntreated childhood brain stem gliomaadult giant cell glioblastomaadult gliosarcoma

Interventions

filgrastimBIOLOGICAL
carboplatinDRUG
thiotepaDRUG
autologous bone marrow transplantationPROCEDURE
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Age6 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Kaplan Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsGlioblastomaAstrocytomaGliosarcoma

Interventions

FilgrastimCarboplatinThiotepaPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsCoordination ComplexesOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsTriethylenephosphoramideAziridinesAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Jonathan L. Finlay, MB, ChB

    NYU Langone Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 11, 2004

Study Start

September 1, 1994

Primary Completion

April 1, 2000

Last Updated

November 9, 2012

Record last verified: 2000-06

Locations

US(1)