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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00278174
First received: January 16, 2006
Last updated: May 2, 2011
Last verified: May 2011
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

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

Enrollment: 7
Study Start Date: February 2005
Study Completion Date: April 2007
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278174

Locations
United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Ronald M. Bukowski, MD The Cleveland Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Ronald M. Bukowski, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00278174     History of Changes
Other Study ID Numbers: CASE15804, P30CA043703, CCF-7752, CASE15804
Study First Received: January 16, 2006
Last Updated: May 2, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 23, 2014