NCT00003467

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of carmustine in treating adults with recurrent supratentorial low-grade glioma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 1998

Longer than 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

January 1, 1998

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
Last Updated

June 20, 2013

Status Verified

October 1, 2009

First QC Date

November 1, 1999

Last Update Submit

June 19, 2013

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumoradult brain stem gliomaadult mixed gliomaadult anaplastic astrocytomaadult pilocytic astrocytomaadult oligodendroglioma

Interventions

carmustineDRUG
polifeprosan 20 with carmustine implantDRUG
surgical procedurePROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed recurrent primary low grade glioma including: * Fibrillary astrocytoma * Oligodendroglioma * Mixed glioma * Evidence of measurable enhancing or non-enhancing CNS neoplasm on MRI PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Hematocrit greater than 29% * Absolute neutrophil count greater than 1500/mm\^3 * Platelet count greater than 125,000/mm\^3 Hepatic: * SGOT less than 1.5 times upper limit of normal (ULN) * Bilirubin less than 1.5 times ULN Renal: * Creatinine less than 1.5 mg/dL * BUN less than 25 mg/dL Other: * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior chemotherapy unless disease progression Endocrine therapy: * Concurrent corticosteroids allowed (must be on stable dose for 1 week prior to study) * No concurrent immunosuppressive agents Radiotherapy: * At least 4 weeks since prior radiotherapy unless disease progression Surgery: * Not specified Other: * No other concurrent medication that may interfere with study

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

Sponsors & Collaborators

Study Sites (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsGliomaAstrocytomaOligodendroglioma

Interventions

CarmustineSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso Compounds

Study Officials

  • Henry S. Friedman, MD

    Duke University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

January 1, 1998

Study Completion

February 1, 2004

Last Updated

June 20, 2013

Record last verified: 2009-10

Locations

US(1)