Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer

• Status: Completed
• Trial end date: 2004-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining bryostatin 1 with interleukin-2 may kill more tumor cells.

PURPOSE: Randomized phase I trial to study the effectiveness of interleukin-2 plus bryostatin 1 in treating patients who have melanoma or kidney cancer that cannot be removed during surgery.

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

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Aldesleukin; Bryostatin 1; Interleukin-2

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed cutaneous or mucosal melanoma or renal cell carcinoma

• Unresectable disease

• No known uncontrolled CNS metastases

• CNS metastases allowed only if recently irradiated or known to be controlled

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Hemoglobin at least 8 g/dL

• WBC at least 3,000/mm^3

• Platelet count at least 100,000/mm^3

• Absolute lymphocyte count at least 1,000/mm^3

Hepatic:

• Total bilirubin no greater than 1.5 mg/dL OR

• Conjugated bilirubin no greater than 0.3 mg/dL

• AST no greater than 2.5 times upper limit of normal

Renal:

• Creatinine no greater than 2 mg/dL

Cardiovascular:

• No myocardial infarction within the past 6 months

• No uncontrolled hypertension, angina, or congestive heart failure

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception during and for 3 months after study

• No known intolerance to acetaminophen

• No primary or secondary immunodeficiency

• No other condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• At least 1 month since prior topical, systemic, or inhaled corticosteroids

• No concurrent topical, systemic, or inhaled corticosteroids

Radiotherapy:

• See Disease Characteristics

Surgery:

• Not specified