A Phase lb Trial of the Combination of Bryostatin-1 and Low Dose Interleukin-2: Evaluation of the Functional and Molecular Status of Human Monocytes as Antigen Presenting Cells

Date de début de l'étude : 1 septembre 1999

DISEASE CHARACTERISTICS: Histologically proven solid tumor or lymphoma that is not curable by surgery, radiotherapy, or standard chemotherapy, or for which no curative therapy exists Prostate cancer patients must have the following: Tumor progression following blockade of both testicular and adrenal androgens Serum testosterone in the castrate range (less than 20 ng/mL) At least 3 months since prior suramin therapy At least 4 weeks since prior flutamide or other antiandrogen medication and no evidence of response to treatment Luprolide should continue if no prior orchiectomy No prior or concurrent brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Life expectancy: At least 3 months Hematopoietic: WBC at least 3,500/mm^3 OR Granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 8 g/dL Hepatic: Hepatitis B surface antigen negative PT no greater than 14 seconds PTT no greater than 35 seconds Bilirubin no greater than 1.5 mg/dL unless due to Gilbert's disease SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN Albumin at least 2.5 g/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Corrected calcium at least 8.0 mg/dL, but no greater than 10.7 mg/dL Cardiovascular: No prior myocardial infarction, coronary artery disease (CAD), congestive heart failure, second or third degree AV block, or cardiac arrhythmias requiring treatment No evidence of CAD on EKG Pulmonary: FEV1-1 at least 70% predicted DLCO at least 60% predicted Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative At least 1 week since active infection requiring antibiotics No other medical or psychiatric condition that would preclude study No prior or concurrent seizure disorders controlled with medication PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior interleukin-2 At least 4 weeks since other prior biologic therapy for solid tumors or lymphomas Chemotherapy: See Disease Characteristics At least 4 weeks since prior bryostatin 1 At least 4 weeks since other prior chemotherapy for solid tumors or lymphomas Endocrine therapy: See Disease Characteristics At least 4 weeks since other prior endocrine therapy for solid tumors or lymphomas No absolute requirement for corticosteroids Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy for solid tumors or lymphomas Surgery: See Disease Characteristics At least 4 weeks since prior surgery for solid tumors or lymphomas Other: No absolute requirement for nonsteroidal anti-inflammatory drugs or H2 blockers