Chemotherapy in Treating Patients With Recurrent Malignant Glioma

NCT ID: NCT00002986

Last Updated: 2013-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-02-28
• Study Completion Date: 2004-05-31

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.

Conditions

Brain and Central Nervous System Tumors

Study Design

• Primary Study Purpose: TREATMENT

Interventions

carmustine

Intervention Type: DRUG

topotecan hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henry S. Friedman, MD

Role: STUDY_CHAIR

Duke Cancer Institute

Locations

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Saint Jude Children's Research Hospital

Memphis, Tennessee, United States

Countries

United States

Other Identifiers

DUMC-000224-01-1R4

Identifier Type: -

Identifier Source: secondary_id

DUMC-000224-00-2R3

Identifier Type: -

Identifier Source: secondary_id

DUMC-0348-99-2R2

Identifier Type: -

Identifier Source: secondary_id

DUMC-223-97-2

Identifier Type: -

Identifier Source: secondary_id

DUMC-229-98-2R1

Identifier Type: -

Identifier Source: secondary_id

SB-DUMC-229-98-2R1

Identifier Type: -

Identifier Source: secondary_id

NCI-G97-1242

Identifier Type: -

Identifier Source: secondary_id

CDR0000065521

Identifier Type: OTHER

Identifier Source: secondary_id

0224

Identifier Type: -

Identifier Source: org_study_id