Expired Study
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Detroit, Michigan 48201


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 plus gemcitabine in treating patients who have advanced cancer that has not responded to previous treatment.


Study summary:

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.


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


NCT ID:

NCT00004144


Primary Contact:

Study Chair
Philip A. Philip, MD, PhD, FRCP
Barbara Ann Karmanos Cancer Institute


Backup Contact:

N/A


Location Contact:

Detroit, Michigan 48201
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

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