Administratively complete.

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.

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