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Home > "S" Clinical Trials Conditions > SU5416 and Interferon alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer  SU5416 and Interferon alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer
SU5416 and Interferon alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer
For Condition: stage 4 renal cell cancer,recurrent renal cell cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Beckman Research Institute
Synopsis: RATIONALE: SU5416 may stop the growth of kidney cancer by stopping blood flow to the tumor. Interferon alfa-2b may interfere with the growth of the cancer cells. Combining interferon alfa-2b with SU5416 may be an effective treatment for kidney cancer. PURPOSE: Phase II trial to study the effectiveness of combining SU5416 and interferon alfa-2b in treating patients who have unresectable or metastatic kidney cancer.
Details: OBJECTIVES: I. Determine the efficacy and toxicity of SU5416 combined with interferon alfa-2b in patients with unresectable or metastatic renal cell carcinoma. PROTOCOL OUTLINE: This is a multicenter study. Patients receive SU5416 IV over 30-60 minutes twice weekly and interferon alfa-2b subcutaneously every 12 hours daily. Treatment continues every 6 weeks for a minimum of 2 courses. Patients who achieve partial response or stable disease after completion of course 2 receive additional courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response may receive additional courses, at the discretion of the protocol investigator, in the absence of disease progression or unacceptable toxicity. Patients with disease progression are allowed to stay on the study until any measurable lesion increases to over 100% of baseline measurement. Patients are followed for survival. PROJECTED ACCRUAL: A total of 20-31 patients will be accrued for this study within 12-18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed unresectable or metastatic renal cell carcinoma - Measurable or evaluable disease - Prior nephrectomy allowed if documented disease progression prior to study - No known brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: At least 8 weeks since prior interleukin-2 and recovered; No other prior biologic therapy - Chemotherapy: At least 4 weeks since prior chemotherapy and recovered; No more than 1 prior chemotherapy regimen - Endocrine therapy: Not specified - Radiotherapy: At least 4 weeks since prior radiotherapy; No concurrent radiotherapy to measurable lesions - Surgery: See Disease Characteristics; More than 3 weeks since prior major surgery --Patient Characteristics-- - Age: 18 and over - Performance status: SWOG 0-2 - Life expectancy: At least 12 weeks - Hematopoietic: WBC at least 3,500/mm3; Absolute granulocyte count at least 1,500/mm3; Platelet count at least lower limit of normal - Hepatic: Bilirubin no greater than 1.5 mg/dL; SGOT no greater than 2 times upper limit of normal - Renal: Creatinine clearance at least 60 mL/min OR Creatinine no greater than 1.5 mg/dL - Cardiovascular: No uncompensated coronary artery disease by ECG or physical examination; No myocardial infarction or severe/unstable angina within the past 6 months; No severe peripheral vascular disease associated with diabetes mellitus; No deep venous or arterial thrombosis within the past 3 months - Pulmonary: No pulmonary embolism within the past 3 months - Other: No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix; Not pregnant or nursing; Fertile patients must use effective contraception; No documented hypersensitivity to any excipients (Cremophor, ethanol, or polyethylene glycol) of SU5416
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PrimoLara, Study Chair, Beckman Research Institute
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
United States
Additional Information:
Study ID Numbers: CDR0000068262; NCI-T99-0085,CHNMC-PHII-23
Study Start Date: November 2000
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006384
Other Recurrent Renal Cell Cancer Studies:
1. Pentostatin Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Kidney Cancer
2. SU5416 and Interferon alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer
3. Flavopiridol in Treating Patients With Unresectable or Metastatic Kidney Cancer
4. SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous Treatment
5. Erlotinib in Treating Patients With Advanced Kidney Cancer
Related Studies:
Other recurrent renal cell cancer Clinical Trials
Other California Clinical Trials
Other Duarte Clinical Trials
SU5416 and Interferon alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer
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