NCT00002986

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of topotecan plus carmustine in patients with recurrent primary malignant glioma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 1997

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

February 1, 1997

Completed
2.7 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
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
Last Updated

February 20, 2013

Status Verified

February 1, 2013

Enrollment Period

7.2 years

First QC Date

November 1, 1999

Last Update Submit

February 15, 2013

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumor

Interventions

carmustineDRUG
topotecan hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven recurrent primary malignant glioma * Measurable recurrent or residual primary central nervous system neoplasm confirmed by MRI PATIENT CHARACTERISTICS: Age: * 18 and over Performance Status: * Karnofsky at least 60% Hematopoietic: * Hematocrit greater than 29% * ANC greater than 1,500/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 * Effective contraceptive method must be used for the duration of the study PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy within 6 weeks of study * No prior topotecan or carmustine treatment failure * No more than 1 prior chemotherapy regimen Endocrine therapy: * Patients taking corticosteroids must be on stable dose for at least 2 weeks prior to study and the dose should not escalate over entry level Radiotherapy: * No prior radiotherapy within 6 weeks of study Surgery: * No prior surgical resection within 3 weeks of study Other: * No concurrent medication that may interfere with study results

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

Sponsors & Collaborators

Study Sites (2)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Saint Jude Children's Research Hospital

Memphis, Tennessee, 38105-2794, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain Neoplasms

Interventions

CarmustineTopotecan

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBrain DiseasesCentral Nervous System Diseases

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

January 27, 2003

Study Start

February 1, 1997

Primary Completion

May 1, 2004

Study Completion

May 1, 2004

Last Updated

February 20, 2013

Record last verified: 2013-02

Locations

US(2)