A Phase I Trial of Bizelesin (NSC 615291) Using a Single Bolus Infusion Given Every Twenty-eight (28) Days in Patients With Advanced Cancer
bizelesin
Treatment Study
Summary
Study start date: August 1, 1997
Actual date on which the first participant was enrolled.OBJECTIVES: I. Determine the maximum tolerated dose of bizelesin in patients with advanced cancer. II. Determine the qualitative and quantitative toxic effects of this therapy in these patients. III. Determine the pharmacokinetics of this therapy in these patients. IV. Determine the recommended dose of this drug for phase II trials. V. Determine the antitumor effects of this therapy in these patients. OUTLINE: This is a dose-escalation study. Patients receive bizelesin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of bizelesin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.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.Criteria
DISEASE CHARACTERISTICS: Histologically confirmed malignant solid tumor for which there are no therapeutic options that are potentially curative or have been demonstrated to increase survival No primary or metastatic CNS malignancy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin normal SGOT no greater than 2.5 times upper limit of normal Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular: No atrial or ventricular arrhythmia requiring medication No ischemic event within the past 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection No other active malignancy except curatively treated carcinoma in situ of the cervix or basal cell skin cancer No other serious concurrent medical illness No history of seizure disorder requiring active therapy PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to more than 10% of bone marrow No prior electron-beam radiotherapy At least 4 weeks since other prior radiotherapy Surgery: Prior surgery allowed Other: Recovered from prior therapy
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
Brooke Army Medical Center
Fort Sam Houston, United StatesOpen Brooke Army Medical Center in Google MapsCancer Therapy & Research Center
San Antonio, United States