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Chemotherapy in Treating Patients With Recurrent Malignant Glioma

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
carmustine
topotecan hydrochloride
Sponsored by
Duke University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent adult brain tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke Comprehensive Cancer Center
  • Saint Jude Children's Research Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
February 15, 2013
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT00002986
Brief Title
Chemotherapy in Treating Patients With Recurrent Malignant Glioma
Official Title
Phase I Treatment of Adults With Primary Malignant Glioma With Topotecan (NSC #609699) Plus BCNU (NSC #409962)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
February 1997 (undefined)
Primary Completion Date
May 2004 (Actual)
Study Completion Date
May 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: Determine the maximum tolerated dose of topotecan administered in combination with a fixed dose of carmustine. Determine the toxic effects of topotecan and carmustine in patients with recurrent primary malignant glioma. OUTLINE: Topotecan is administered by an ambulatory infusion pump for 72 hours each week. Topotecan dose escalation is carried out in cohorts of three patients. Dose escalation is continued until toxic effects or disease progression is observed in these patients. Carmustine is administered over 1 hour every 6 weeks, on the same day as the first topotecan dose for that week. Three patients will be treated at an initial dose level of topotecan, and if one of these patients experience dose limiting toxicity (DLT), an additional 3 patients must be treated at this dose level without further DLT in order for dose escalation to proceed. The MTD is the highest dose at which DLT occurs in no more than 1 of 6 patients. Patients are evaluated after every 6 week cycle. PROJECTED ACCRUAL: An estimated 18-36 patients will be entered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
recurrent adult brain tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carmustine
Intervention Type
Drug
Intervention Name(s)
topotecan hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry S. Friedman, MD
Organizational Affiliation
Duke Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Saint Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105-2794
Country
United States

12. IPD Sharing Statement

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Chemotherapy in Treating Patients With Recurrent Malignant Glioma

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