NCT00003463

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of carmustine wafers plus irinotecan in treating patients with recurrent supratentorial high grade gliomas.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jul 1998

Longer than P75 for phase_1

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

July 1, 1998

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2002

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

September 25, 2003

Completed
Last Updated

February 18, 2013

Status Verified

February 1, 2013

Enrollment Period

4 years

First QC Date

November 1, 1999

Last Update Submit

February 15, 2013

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumoradult brain stem gliomaadult glioblastomaadult anaplastic astrocytomaadult mixed gliomaadult giant cell glioblastomaadult gliosarcoma

Interventions

carmustineDRUG
irinotecan hydrochlorideDRUG
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 supratentorial glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma * Must be able to undergo surgical resection * At least 1 bidimensionally measurable lesion documented on Gd-MRI within 72 hours after surgical implantation of Gliadel wafers * Not requiring immediate radiotherapy PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * Greater than 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 125,000/mm\^3 * Hematocrit at least 29% Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * SGOT or SGPT less than 2.5 times ULN * Alkaline phosphatase less than 2 times ULN Renal: * BUN less than 1.5 times ULN * Creatinine less than 1.5 times ULN Neurological: * Must be neurologically stable Other: * HIV negative * No AIDS-related illness * No nonmalignant systemic disease that would make patient a poor medical risk * No acute infection requiring intravenous antibiotics * Not pregnant or nursing * Negative pregnancy test 24 hours prior to study * Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior irinotecan * At least 6 weeks since chemotherapy unless there is unequivocal evidence of tumor progression after chemotherapy Endocrine therapy: * At least 1 week of nonincreasing dose of steroids prior to study Radiotherapy: * At least 6 weeks since radiotherapy unless there is unequivocal evidence of tumor progression after radiotherapy * No concurrent radiotherapy Surgery: * Not specified

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

Sponsors & Collaborators

Study Sites (2)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsGlioblastomaAstrocytomaGliomaGliosarcoma

Interventions

CarmustineIrinotecanSurgical 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 CompoundsCamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Henry S. Friedman, MD

    Duke Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

September 25, 2003

Study Start

July 1, 1998

Primary Completion

July 1, 2002

Study Completion

July 1, 2002

Last Updated

February 18, 2013

Record last verified: 2013-02

Locations

US(2)