Bryostatin 1 and Interleukin-2 in Treating Patients With Refractory Solid Tumors or Lymphoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy 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 chemotherapy and interleukin-2 may kill more cancer cells.

PURPOSE: 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute on Aging (NIA)
• Collaborator: National Cancer Institute (NCI)
• Treatments: Aldesleukin; Bryostatin 1; Interleukin-2

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:

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