Phase I Study of Bryostatin 1 and Gemcitabine (Gemzar)

Date de début de l'étude : 1 mai 2000

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