Patient case: 55-year-old male with Melanoma. Genetic variant: NRAS (Q61K). Other conditions: Hypertension.

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

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.

Eligibility: 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

Relevance to patient case: not relevant