Full Text View
Tabular View
No Study Results Posted
Related Studies
Interferon Alfa in Treating Patients With Metastatic Kidney Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), July 2008
First Received: January 16, 2006   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00278174
  Purpose

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 Intervention Phase
Kidney Cancer
Biological: recombinant interferon alpha-1b
Phase II

MedlinePlus related topics: Cancer Kidney Cancer
Drug Information available for: Interferon alfa-2a Interferon alfa-n1 Interferons
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Trial of Interferon Alpha-1b (IFN Alpha-1b) in Patients With Metastatic Clear Cell Renal Carcinoma

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

Primary Outcome Measures:
  • Safety [ Designated as safety issue: Yes ]
  • Efficacy [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2005
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

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

Secondary

  • 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.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00278174

Locations
United States, Ohio
Cleveland Clinic Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente     866-223-8100        
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Ronald M. Bukowski, MD The Cleveland Clinic
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000446100, CASE-CCF-7752, CASE-CCF-15804
Study First Received: January 16, 2006
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00278174     History of Changes
Health Authority: Unspecified

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

Study placed in the following topic categories:
Interferon-alpha
Urinary Tract Neoplasm
Interferon Type I, Recombinant
Kidney Cancer
Immunologic Factors
Interferons
Urogenital Neoplasms
Urologic Neoplasms
Angiogenesis Inhibitors
Antiviral Agents
Recurrence
Carcinoma
Renal Cancer
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Clear Cell Renal Cell Carcinoma
Kidney Diseases
Interferon Alfa-2a
Adenocarcinoma
Neoplasms, Glandular and Epithelial

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
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009