Expired Study
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Houston, Texas 77030


Purpose:

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


Study summary:

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.


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


NCT ID:

NCT00009919


Primary Contact:

Principal Investigator
Arlene Siefker-Radtke
M.D. Anderson Cancer Center


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 23, 2017

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