Know Cancer

forgot password

Phase II Trial of SU5416 and Interferon Alfa 2B in Unresectable or Metastatic Renal Cell Carcinoma

Phase 2
18 Years
Not Enrolling
Kidney Cancer

Thank you

Trial Information

Phase II Trial of SU5416 and Interferon Alfa 2B in Unresectable or Metastatic Renal Cell Carcinoma

OBJECTIVES: I. Determine the efficacy and toxicity of SU5416 combined with interferon
alfa-2b in patients with unresectable or metastatic renal cell carcinoma.

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

Inclusion 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

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 no greater
than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min 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 EL, ethanol, or polyethylene glycol) of SU5416

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Primo N. Lara, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, Davis


United States: Federal Government

Study ID:




Start Date:

November 2000

Completion Date:

February 2007

Related Keywords:

  • Kidney Cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Cancer Center and Beckman Research Institute, City of Hope Duarte, California  91010-3000
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
University of California Davis Cancer Center Sacramento, California  95817