17-n-allylamino-17-demethoxygeldanamycin in treating patients with metastatic kidney cancer

Conditions: Kidney Cancer

Summary: rationale: drugs used in chemotherapy, such as 17-n-allylamino-17-demethoxygeldanamycin, work in different ways to stop tumor cells from dividing so they stop growing or die. 17-n-allylamino-17-demethoxygeldanamycin may also stop the growth of tumor cells by blocking the enzymes necessary for their growth. purpose: this phase ii trial is studying how well 17-n-allylamino-17-demethoxygeldanamycin works in treating patients with metastatic kidney cancer.

objectives: primary * determine the efficacy of 17-n-allylamino-17-demethoxygeldanamycin (17-aag) in patients with metastatic papillary or clear cell renal cell carcinoma. secondary * determine the safety of this drug in these patients. * correlate tumor c-met expression with response in patients treated with this drug. outline: this is an open-label study. patients are stratified according to histology (papillary vs clear cell). patients receive 17-n-allylamino-17-demethoxygeldanamycin (17-aag) iv over 60-90 minutes on days 1, 4, 8, and 11. treatment repeats every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. patients are followed at 3 weeks and then every 3 months thereafter. projected accrual: a total of 24-74 patients (12-37 per stratum) will be accrued for this study within 6-20 months (clear cell stratum) and 2-5 years (papillary stratum).

Eligibility criteria:
disease characteristics: * histologically confirmed renal cell carcinoma * papillary or clear cell histology * if other histologies are present, clear cell or papillary must be predominant * metastatic disease * measurable disease * at least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral ct scan * no brain metastases unless previously treated with radiotherapy or surgery and asymptomatic with no active brain metastases detectable by ct scan or mri for ≥ 6 months patient characteristics: age * 18 and over performance status * karnofsky 70-100% life expectancy * not specified hematopoietic * wbc ≥ 3,000/mm\^3 * absolute neutrophil count ≥ 1,500/mm\^3 * platelet count ≥ 100,000/mm\^3 hepatic * ast and alt ≤ 1.5 times upper limit of normal (uln) * bilirubin ≤ 1.5 times uln renal * creatinine ≤ 2.0 times uln cardiovascular * no symptomatic congestive heart failure * no unstable angina pectoris * no cardiac arrhythmia * no severe valvular disease pulmonary * no severe debilitating pulmonary disease other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no allergy to egg or egg products * no history of allergic reactions attributed to compounds of similar chemical or biological composition to 17-n-allylamino-17-demethoxygeldanamycin (17-aag) * no active or ongoing infection requiring iv antibiotics * no psychiatric illness or social situation that would preclude study compliance * no other uncontrolled illness prior concurrent therapy: biologic therapy * no more than 1 prior cytokine-based regimen * no concurrent biologic therapy chemotherapy * more than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) endocrine therapy * not specified radiotherapy * more than 4 weeks since prior radiotherapy * no concurrent radiotherapy surgery * more than 4 weeks since prior major surgery other * recovered from prior therapy * no more than 1 prior non-cytokine-based regimen * no other prior systemic treatment regimens * no other concurrent cytotoxic therapy * no other concurrent anticancer therapy * no other concurrent investigational agents

Keywords: recurrent renal cell cancer stage iv renal cell cancer clear cell renal cell carcinoma