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

Virginia Commonwealth University17 enrolled

Overview

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.

OBJECTIVES: * Determine the dose of bryostatin 1 that, when administered in conjunction with low-dose interleukin-2, maximizes in vitro interleukin-2- stimulated peripheral blood stem cell proliferation in patients with melanoma or renal cell carcinoma. * Assess other intermediate markers of immune response in patients treated with this regimen. * Determine tumor responses, response durations, progression-free intervals, and survival of patients treated with this regimen. OUTLINE: This is a randomized, double-blind study. Patients are randomized to one of three bryostatin 1 dose levels. Patients receive interleukin-2 subcutaneously daily on days 1-5 and bryostatin 1 IV over 1 hour on day 1 weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 21 patients will be accrued for this study within 2 years.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Kidney Cancer Melanoma (Skin)

Interventions

aldesleukinBIOLOGICAL

bryostatin 1DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (2)

Norris Cotton Cancer Center

Lebanon, New Hampshire, United States

Massey Cancer Center

Richmond, Virginia, United States

Data from ClinicalTrials.gov

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