su5416 in treating patients with metastatic kidney cancer that has not responded to previous treatment

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

Summary: phase ii trial to study the effectiveness of su5416 in treating patients who have metastatic kidney cancer that has not responded to previous therapy with interleukin-2. su5416 may stop the growth of kidney cancer by stopping blood flow to the tumor

objectives: i. determine the clinical activity of su5416 in patients with progressive metastatic renal cancer failing prior biologic therapy or fluorouracil-containing regimens. ii. determine the changes in tumor perfusion in patients treated with this regimen. iii. determine the time to progression and survival in patients treated with this regimen. outline: patients receive su5416 iv over 1 hour twice weekly. treatment continues every 6 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. patients with complete response (cr) receive an additional 6 months of therapy after achieving cr. patients are followed every 3 months.

Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic renal cell carcinoma * prior removal of primary tumors * bidimensionally measurable disease * bone-only disease is not considered measurable * progressive disease following no more than 2 prior biologic therapy (e.g.,interleukin-2, interferon alfa, vaccine, or dendritic cell therapy) orfluorouracil-containing (single-agent or in combination therapy) regimens * no known history of cns metastasis unless all of the following are true: * previously treated * neurologically stable * no requirement for iv steroids or anticonvulsants * no requirement for oral steroids and no evidence of active or residual cns disease on ct scan or mri * negative brain scan (ct scan or mri) required if neurologic signs or symptoms suggestive of cns metastasis present * performance status - zubrod 0-2 * at least 12 weeks * absolute neutrophil count at least 1,500/mm\^3 * platelet count greater than 100,000/mm\^3 * bilirubin no greater than 1.5 mg/dl * sgpt no greater than 2.5 times upper limit of normal * pt and ptt normal * fibrinogen normal * d-dimer assay normal * creatinine no greater than 1.5 mg/dl * creatinine clearance at least 60 ml/min * see surgery * no active congestive heart failure * no uncontrolled angina * no myocardial infarction or severe/unstable angina within the past 6 months * no uncontrolled hypertension * no uncompensated coronary artery disease on electrocardiogram or physical examination * no severe peripheral vascular disease * no deep vein or arterial thrombosis within the past 3 months * no pulmonary embolism within the past 3 months * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no concurrent serious infection * no overt psychosis, mental disability, or incompetence * no diabetes mellitus * no other prior malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix * no hypersensitivity or allergic reaction to paclitaxel * see disease characteristics * no other concurrent anti-cancer biologic therapy * see disease characteristics * no concurrent anti-cancer chemotherapy * see disease characteristics * at least 4 weeks since prior radiotherapy and recovered * no sole indicator lesion within the previously irradiated port * no concurrent anti-cancer radiotherapy * see disease characteristics * at least 4 weeks since prior major surgery and recovered * at least 1 year since prior bypass surgery for atherosclerotic coronary artery disease * no concurrent surgery for cancer * no other investigational drugs (e.g., analgesics or antiemetics) for at least 28 days prior to and after study