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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
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.

Official Title
-----------------
Phase IA/IB Trial of Modulation of the Biological Response to Interleukin-2 (IL-2) With Bryostatin 1 (BRYO; NSC 339555)

Conditions
-----------------
Kidney Cancer, Melanoma (Skin)

Intervention / Treatment
-----------------
* Biological: aldesleukin
* Drug: bryostatin 1


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: aldesleukin|nan|
|Drug: bryostatin 1|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer, stage III melanoma, stage IV melanoma, recurrent melanoma