SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous Treatment

Stopped early · Phase 2

Conditions studied: Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer

In brief

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

Key facts

Study ID

NCT00009919

Run by

National Cancer Institute (NCI)

People needed

50

Starts

2000-12-01

Last updated by the study team

2013-01-23

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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