Interferon Alfa (IFN-Alpha-1b) in Renal Cancer With Metastatic Kidney Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00278174 |
Recruitment Status
:
Completed
First Posted
: January 18, 2006
Last Update Posted
: May 4, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 (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 |

- Safety
- Efficacy

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Ohio | |
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44195 |
Study Chair: | Ronald M. Bukowski, MD | The Cleveland Clinic |
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 |