Phase I Study of Bryostatin 1 and Gemcitabine (Gemzar)
bryostatin 1
+ gemcitabine hydrochloride
Treatment Study
Summary
Study start date: May 1, 2000
Actual date on which the first participant was enrolled.OBJECTIVES: Determine the maximum tolerated dose of gemcitabine when given concurrently with bryostatin 1 to patients with advanced refractory cancer. Access the pattern of toxicity of this drug regimen in this patient population. Determine the objective response rate, duration of response, and overall survival in patients treated with this drug regimen. Determine the influence of bryostatin 1 on the pharmacokinetics of gemcitabine. OUTLINE: This is a dose escalation study. Patients receive gemcitabine IV over 30 minutes, immediately followed by bryostatin 1 IV over 24 hours, weekly for 3 weeks (days 1, 8, and 15). Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of gemcitabine and bryostatin 1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxic effects. PROJECTED ACCRUAL: Approximately 2-3 patients per month 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.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.Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically proven advanced cancer (except hematological cancers) for which there is no standard therapy or have failed standard therapies Measurable or evaluable disease Clinically controlled brain metastases allowed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: At least 3 months Hematopoietic: Hemoglobin at least 8.0 g/dL Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) (elevated bilirubin due to Gilbert's syndrome allowed if direct bilirubin normal) AST less than 2.5 times ULN Renal: Creatinine normal Cardiovascular: No active cardiac disease Other: Not pregnant or nursing Fertile patients must use effective contraception No concurrent bacterial infection requiring antibiotics No serious concurrent medical condition PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: At least 3 weeks since systemic cytotoxic chemotherapy (including gemcitabine) and recovered No other concurrent chemotherapy Endocrine therapy: Prior hormonal therapy allowed No concurrent hormonal therapy (excluding contraceptives, appetite stimulants, or replacement steroids) Radiotherapy: At least 3 weeks since radiotherapy to large areas of active bone marrow and recovered No concurrent radiotherapy Surgery: Recovered from prior major surgery Other: No concurrent antiviral nucleosides At least 1 month since prior investigational agents No other concurrent experimental medications
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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 1 location
Barbara Ann Karmanos Cancer Institute
Detroit, United StatesOpen Barbara Ann Karmanos Cancer Institute in Google Maps