Phase I Treatment of Adults With Primary Malignant Glioma With Topotecan (NSC #609699) Plus BCNU (NSC #409962)
18 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
Phase I Treatment of Adults With Primary Malignant Glioma With Topotecan (NSC #609699) Plus BCNU (NSC #409962)
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.
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Henry S. Friedman, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Duke Cancer Institute
Authority:
United States: Federal Government
Study ID:
0224
NCT ID:
NCT00002986
Start Date:
February 1997
Completion Date:
May 2004
Related Keywords:
- Brain and Central Nervous System Tumors
- recurrent adult brain tumor
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Glioma
Name | Location |
|---|---|
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| Saint Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
