Trial Information

Summary: A Phase 1b 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

Drugs used in treatment of cancer, such as bryostatin-1, use different ways to stop cancer cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining bryostatin-1 and interleukin-2 may kill more cancer cells.

This phase I trial is studying the side effects and best dose of interleukin-2 when given together with bryostatin-1 in treating patients with refractory solid tumors or lymphoma.

Eligibility: Men and women 18 Years and above.

Criteria

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:

Performance status:

• ECOG 0 or 1: Ambulatory and able to carry out work of a light or sedentary nature without assistance.

Life expectancy:

• At least 3 months

Hematopoietic:

• WBC at least 3,500/mm 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

If you would like to learn more about participating in this study, please send an e-mail message using the form below.