Working… Menu
Trial record 10 of 10 for:    "Clear Cell Renal Cell Carcinoma" | "Interferon alpha-2"

Interferon Alfa (IFN-Alpha-1b) in Renal Cancer With Metastatic Kidney Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00278174
Recruitment Status : Completed
First Posted : January 18, 2006
Last Update Posted : May 4, 2011
National Cancer Institute (NCI)
Information provided by:
Case Comprehensive Cancer Center

Brief Summary:

RATIONALE: Interferon alfa may interfere with the growth of tumor cells and slow the growth of kidney cancer.

PURPOSE: This phase II trial is studying how well interferon alfa works in treating patients with metastatic kidney cancer.

Condition or disease Intervention/treatment Phase
Kidney Cancer Biological: recombinant interferon alpha-1b Phase 2

Detailed Description:



  • Determine the objective response rate in patients with metastatic renal clear cell carcinoma treated with interferon alfa-1b.


  • Determine the toxicity of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive interferon alfa-1b subcutaneously daily. Treatment continues in the absence of unacceptable toxicity or disease progression.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Interferon Alpha-1b (IFN Alpha-1b) in Patients With Metastatic Clear Cell Renal Carcinoma
Study Start Date : February 2005
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Primary Outcome Measures :
  1. Safety
  2. Efficacy

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed predominantly renal clear cell carcinoma

    • Clinical evidence of OR biopsy-proven metastatic disease to a site or sites distant from the primary tumor
  • Must have measurable disease, defined as ≥ 1 unidimensionally measurable lesion measured as ≥ 20 mm with conventional techniques OR as ≥ 10 mm with spiral CT scan
  • Good- or intermediate-risk category as defined by having ≤ 2 of the following factors:

    • Time from initial diagnosis to treatment < 1 year
    • Karnofsky performance status < 80%
    • Hemoglobin < lower limit of normal
    • Corrected calcium > 10.0 mg/dL
    • Lactate dehydrogenase (LDH) > 1.5 times upper limit of normal (ULN)
  • No major clinical ascites or pleural effusion
  • No CNS metastases by neurologic exam and CT scan or MRI


  • ECOG performance status 0-1
  • Life expectancy ≥ 3 months
  • WBC ≥ 3,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.5 g/dL
  • Creatinine ≤ 1.5 mg/dL (2.0 mg/dL in post-nephrectomy patients)
  • Calcium normal
  • Total bilirubin ≤ 1.5 mg/dL
  • AST ≤ 3.0 times normal
  • Alkaline phosphatase ≤ 2.5 times normal (10 times ULN in presence of bone metastases)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception prior to and for the duration of study treatment
  • No history of serious cardiac arrhythmia, congestive heart failure, angina pectoris, or other severe cardiovascular disease (i.e., New York Heart Association class III or IV)
  • No known positivity for HIV or hepatitis B surface antigen
  • No history of seizure disorders
  • No local and/or systemic infections requiring antibiotics within 28 days prior to study entry
  • No other malignancy except basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the uterine cervix, or any malignancy treated with curative intent and in complete remission for > 3 years


  • No prior organ allografts
  • No prior interferon
  • No prior cytokine-based therapy for metastatic disease
  • Prior radiotherapy is allowed for the control of pain from skeletal lesions provided treatment was completed > 28 days prior to study entry and patient has recovered
  • No major surgery requiring general anesthesia within 28 days prior to study entry
  • No more than 2 prior therapies for metastatic disease
  • No concurrent palliative radiotherapy
  • No concurrent chemotherapy
  • No concurrent hormonal therapy except for hormones administered for nondisease-related conditions (e.g., insulin for diabetes)
  • No concurrent steroid use except ongoing replacement therapy with physiologic doses of corticosteroids

    • No concurrent dexamethasone or other steroidal anti-emetics or anti-inflammatories
  • No other concurrent anticancer therapy
  • No concurrent aspirin or barbiturates
  • No other concurrent investigational agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00278174

Layout table for location information
United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: Ronald M. Bukowski, MD The Cleveland Clinic

Layout table for additonal information
Responsible Party: Ronald M. Bukowski, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Identifier: NCT00278174     History of Changes
Other Study ID Numbers: CASE15804
P30CA043703 ( U.S. NIH Grant/Contract )
CCF-7752 ( Other Identifier: Cleveland Clinic IRB )
CASE15804 ( Other Identifier: Case Comprehensive Cancer Center )
First Posted: January 18, 2006    Key Record Dates
Last Update Posted: May 4, 2011
Last Verified: May 2011
Keywords provided by Case Comprehensive Cancer Center:
stage IV renal cell cancer
recurrent renal cell cancer
clear cell renal cell carcinoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Interferon alpha-2
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs