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

Primary Purpose

Kidney Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
recombinant interferon alpha-1b
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage IV renal cell cancer, recurrent renal cell cancer, clear cell renal cell carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Safety
Efficacy

Secondary Outcome Measures

Full Information

First Posted
January 16, 2006
Last Updated
May 2, 2011
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00278174
Brief Title
Interferon Alfa (IFN-Alpha-1b) in Renal Cancer With Metastatic Kidney Cancer
Official Title
A Phase II Trial of Interferon Alpha-1b (IFN Alpha-1b) in Patients With Metastatic Clear Cell Renal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
stage IV renal cell cancer, recurrent renal cell cancer, clear cell renal cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
recombinant interferon alpha-1b
Primary Outcome Measure Information:
Title
Safety
Title
Efficacy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald M. Bukowski, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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

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