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

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ClinicalTrials.gov Identifier: NCT00278174

Recruitment Status : Completed

First Posted : January 18, 2006

Last Update Posted : May 4, 2011

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

Case Comprehensive Cancer Center

Study Description

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:

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 Design


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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Drug Information available for: Interferon Interferon Alfa-2a

Genetic and Rare Diseases Information Center resources: Renal Cell Carcinoma Clear Cell Renal Cell Carcinoma

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Safety
Efficacy

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

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 ClinicalTrials.gov identifier (NCT number): 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

National Cancer Institute (NCI)

Investigators


Study Chair:	Ronald M. Bukowski, MD	The Cleveland Clinic

More Information


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 ( 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:


Kidney Neoplasms Carcinoma, Renal Cell Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Kidney Diseases Urologic Diseases Adenocarcinoma Carcinoma	Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Interferons Interferon-alpha Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs

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