interleukin-2 and bryostatin 1 in treating patients with advanced kidney cancer

Conditions: Recurrent Renal Cell Cancer; Stage III Renal Cell Cancer; Stage IV Renal Cell Cancer

Summary: interleukin-2 may stimulate a person's white blood cells to kill tumor cells. drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining bryostatin 1 with interleukin-2 may cause a stronger immune response and kill more tumor cells. randomized phase ii trial to study the effectiveness of combining interleukin-2 and bryostatin 1 in treating patients who have advanced kidney cancer

primary objectives: i. determine the objective response rate in patients with advanced renal cell carcinoma treated with interleukin-2 (il-2) and bryostatin 1. ii. compare the toxicity of 3 different doses of bryostatin 1 given in combination with a fixed dose of il-2 in these patients. outline: this is a randomized, multicenter study. patients are randomized to one of three dose levels of bryostatin 1. arm i: patients receive interleukin-2 (il-2) subcutaneously on days 1-4, 8-11, and 15-18. for the second and subsequent courses of il-2, patients also receive lowest dose bryostatin 1 iv over 1 hour on days 1, 8, and 15. treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. arm ii: patients receive il-2 as in arm i and middle dose bryostatin 1 iv over 1 hour on days 1, 8, and 15. treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. arm iii: patients receive il-2 as in arm i and highest dose bryostatin 1 iv over 1 hour on days 1, 8, and 15. treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. patients with stable or responding disease may receive 3 additional courses of therapy. an additional cohort of patients receives treatment as above at a higher dose to evaluate toxicity. patients are followed for 1 year. projected accrual: a total of 24-65 patients (8-16 per bryostatin 1 dose level) will be accrued for this study within 14-27 months.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed renal cell carcinoma * recurrent or refractory advanced disease * newly diagnosed disease with no appropriate standard therapy available * measurable disease * no active cns metastases * single prior cns metastasis allowed if all of the following are true: * previously resected and irradiated * no evidence of progressive cns disease for at least 8 weeks after completion of therapy * no requirement for steroids or anti-seizure medications * performance status - ecog 0-2 * more than 3 months * wbc at least 3,000/mm\^3 * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 * bilirubin no greater than 1.5 times upper limit of normal (uln) * ast/alt no greater than 2.5 times uln * creatinine no greater than 2.0 mg/dl * no symptomatic congestive heart failure * no unstable angina pectoris * no cardiac arrhythmia * not pregnant or nursing * negative pregnancy test * fertile patients must use effective barrier contraception during and for at least 2 weeks after study for female patients and for 3 months after study for male patients * no concurrent uncontrolled illness * no ongoing or active infection * no psychiatric illness or social situation that would preclude study entry * no prior interleukin-2 * see disease characteristics * see disease characteristics * prior radiotherapy to less than 50% of bone marrow allowed * at least 4 weeks since prior radiotherapy * see disease characteristics * no other concurrent investigational agents * no concurrent combination antiretroviral therapy for hiv-positive patients