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SU5416 and Interferon Alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer
This study has been completed.
First Received: October 4, 2000   Last Updated: February 6, 2009   History of Changes
Sponsor: Beckman Research Institute
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006384
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Biological: recombinant interferon alfa
Drug: semaxanib
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Trial of SU5416 and Interferon Alfa 2B in Unresectable or Metastatic Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 2000
Detailed Description:

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 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006384

Locations
United States, California
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States, 91010-3000
University of California Davis Cancer Center
Sacramento, California, United States, 95817
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
Sponsors and Collaborators
Beckman Research Institute
Investigators
Study Chair: Primo N. Lara, MD University of California, Davis
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000068262, CHNMC-PHII-23, NCI-T99-0085
Study First Received: October 4, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00006384     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:
Anti-Infective Agents
Interferon Type I, Recombinant
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Urologic Neoplasms
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Growth Inhibitors
Kidney Diseases
Angiogenesis Modulating Agents
Interferon-alpha
Neoplasms by Histologic Type
Growth Substances
Interferons
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Carcinoma, Renal Cell
Adenocarcinoma
Interferon Alfa-2a
Interferon Alfa-2b
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 09, 2009