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

A Phase II Trial of Interferon Alpha-1b (IFN Alpha-1b) in Patients With Metastatic Clear Cell Renal Carcinoma

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.

Study Overview

• Status: Completed
• Conditions: Kidney Cancer
• Intervention / Treatment: Biological: recombinant interferon alpha-1b

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety
Efficacy

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: February 1, 2005
• Primary Completion (Actual): April 1, 2007
• Study Completion (Actual): April 1, 2007

Study Registration Dates

• First Submitted: January 16, 2006
• First Submitted That Met QC Criteria: January 16, 2006
• First Posted (Estimate): January 18, 2006

Study Record Updates

• Last Update Posted (Estimate): May 4, 2011
• Last Update Submitted That Met QC Criteria: May 2, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: stage IV renal cell cancer; recurrent renal cell cancer; clear cell renal cell carcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Interferons; Interferon-alpha; Interferon-alfa-1b
• Other Study ID Numbers: CASE15804 (Other Identifier: Case Comprehensive Cancer Center); P30CA043703 (U.S. NIH Grant/Contract); CCF-7752 (Other Identifier: Cleveland Clinic IRB)