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

NCT ID: NCT00278174

Last Updated: 2011-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2007-04-30

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.

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.

Conditions

Kidney Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

recombinant interferon alpha-1b

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Principal Investigators

Ronald M. Bukowski, MD

Role: STUDY_CHAIR

The Cleveland Clinic

Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CCF-7752

Identifier Type: OTHER

Identifier Source: secondary_id

CASE15804

Identifier Type: OTHER

Identifier Source: secondary_id

CASE15804

Identifier Type: -

Identifier Source: org_study_id