Phase I Treatment of Adults With Primary Malignant Glioma With Topotecan (NSC #609699) Plus BCNU (NSC #409962)
carmustine
+ topotecan hydrochloride
Brain Diseases+5
+ Central Nervous System Diseases
+ Neoplasms
Treatment Study
Summary
Study start date: February 1, 1997
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.36 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Duke Comprehensive Cancer Center
Durham, United StatesOpen Duke Comprehensive Cancer Center in Google MapsSaint Jude Children's Research Hospital
Memphis, United States