Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific
Brief summary
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.
Detailed description
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.
Interventions
DRUGbryostatin 1
DRUGgemcitabine hydrochloride
Sponsors
National Cancer Institute (NCI)
Barbara Ann Karmanos Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed