NCT00008008

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy with peripheral stem cell or bone marrow transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: This phase II trial is studying how well thiotepa followed by peripheral stem cell or bone marrow transplant works in treating patients with malignant glioma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 1997

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1997

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2001

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

February 4, 2013

Status Verified

July 1, 2007

Enrollment Period

7.8 years

First QC Date

January 6, 2001

Last Update Submit

February 1, 2013

Conditions

Brain and Central Nervous System Tumors

Keywords

childhood infratentorial ependymomachildhood supratentorial ependymomarecurrent adult brain tumoradult medulloblastomaadult glioblastomaadult oligodendrogliomachildhood high-grade cerebral astrocytomachildhood oligodendrogliomaadult anaplastic astrocytomaadult anaplastic ependymomaadult mixed gliomarecurrent childhood supratentorial primitive neuroectodermal tumorrecurrent childhood cerebellar astrocytomarecurrent childhood cerebral astrocytomarecurrent childhood ependymomaadult giant cell glioblastomaadult gliosarcomaadult supratentorial primitive neuroectodermal tumor (PNET)

Outcome Measures

Primary Outcomes (4)

  • Response rate

  • Disease-free interval

  • Overall survival

  • Toxicity

Secondary Outcomes (2)

  • Pharmacokinetics

  • Presence of high-dose thiotepa in the cerebrospinal fluid

Interventions

filgrastimBIOLOGICAL
sargramostimBIOLOGICAL
cyclophosphamideDRUG
thiotepaDRUG
autologous bone marrow transplantationPROCEDURE
bone marrow ablation with stem cell supportPROCEDURE
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed malignant glioma * Primary or recurrent glioblastoma multiforme (including gliosarcoma) following surgery and radiotherapy or prior conventional chemotherapy (e.g., carmustine or procarbazine, vincristine, and lomustine) * Recurrent or refractory anaplastic astrocytoma following any prior therapy (must be chemoresistant) * Recurrent or refractory ependymoma or primitive neuroectodermal tumor (PNET) following any prior therapy * Recurrent or refractory oligodendroglioma or oligoastrocytoma following any prior therapy (must be chemoresistant) * Evaluable disease on gadolinium-enhanced MRI * Ineligible for other high priority national or institutional study (e.g., protocol CAMP-004) PATIENT CHARACTERISTICS: Age: * Any age Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Creatinine less than 1.5 times normal Cardiovascular: * LVEF at least 45% by MUGA Pulmonary: * DLCO at least 60% of predicted OR * Approval by pulmonologist Other: * Not pregnant or nursing * Fertile patients must use effective contraception * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * No other concurrent chemotherapy Endocrine therapy: * No concurrent anticancer hormonal therapy * No concurrent steroids as antiemetics Radiotherapy: * See Disease Characteristics * See Surgery Surgery: * See Disease Characteristics * For patients with glioblastoma multiforme, concurrent surgery and/or stereotactic radiosurgery to reduce tumor bulk allowed Other: * No concurrent acetaminophen during chemotherapy

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

Sponsors & Collaborators

Study Sites (2)

St. Joseph's Hospital and Medical Center

Paterson, New Jersey, 07503, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsMedulloblastomaGlioblastomaOligodendrogliomaAstrocytomaEpendymomaGliomaFamilial ependymomaGliosarcoma

Interventions

FilgrastimsargramostimCyclophosphamideThiotepaPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBrain DiseasesCentral Nervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeuroectodermal Tumors, PrimitiveNeoplasms, 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 FactorsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsTriethylenephosphoramideAziridinesAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Charles S. Hesdorffer, MD

    Herbert Irving Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2001

First Posted

January 27, 2003

Study Start

September 1, 1997

Primary Completion

June 1, 2005

Study Completion

May 1, 2008

Last Updated

February 4, 2013

Record last verified: 2007-07

Locations

US(2)