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Interferon Alfa and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

Primary Purpose

Kidney Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aldesleukin
recombinant interferon alfa
conventional surgery
Sponsored by
Blumenthal Cancer Center at Carolinas Medical 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

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically proven renal cell cancer that is metastatic No greater than 50% estimated hepatic replacement by tumor on CT or MRI No symptomatic involvement of the CNS or a major nerve Measurable disease required Ineligible for treatment with low-dose interleukin-2 on another CMC protocol PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50%-100% Life expectancy: More than 3 months Hematopoietic: No coagulopathy (i.e., platelet count less than 80,000/mm3) Hepatic: AST and ALT no greater than 5 times normal Renal: Creatinine less than 4.0 mg/dL Cardiovascular: No symptomatic angina No untreated coronary artery disease No refractory arrhythmia No abnormal left ventricular function Pulmonary: No dyspnea on minimal exertion Other: No site of ongoing bleeding No systemic infection No HIV antibody No HBsAg No requirement for steroids No psychiatric disease that precludes informed consent or protocol treatment No second malignancy except: Basal cell skin carcinoma Carcinoma in situ of the cervix Not pregnant or nursing Effective contraception required of fertile women PRIOR CONCURRENT THERAPY: Biologic therapy No prior interleukin-2 Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other At least 28 days since prior treatment for renal cell cancer

Sites / Locations

  • Blumenthal Cancer Center at Carolinas Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
December 18, 2013
Sponsor
Blumenthal Cancer Center at Carolinas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00002847
Brief Title
Interferon Alfa and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
Official Title
TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH SUBCUTANEOUS RECOMBINANT INTERLEUKIN-2 AND INTERFERON ALPHA
Study Type
Interventional

2. Study Status

Record Verification Date
December 2003
Overall Recruitment Status
Unknown status
Study Start Date
September 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Blumenthal Cancer Center at Carolinas Medical Center

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Biological therapies use different ways to stimulate the immune system to try to stop cancer cells from growing. Combining interferon alfa and interleukin-2 may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of interferon alfa and interleukin-2 in treating patients with metastatic kidney cancer.
Detailed Description
OBJECTIVES: Evaluate the response and disease-free survival of patients with metastatic renal cell carcinoma treated with subcutaneous interleukin-2 and interferon alfa. Assess the toxicity of this regimen. OUTLINE: Patients undergo nephrectomy if the diseased kidney makes up the bulk of the tumor burden. All patients receive subcutaneous interferon alfa on day 1 and interleukin-2 on days 3-5 of week 1, followed by reduced doses of interferon alfa and interleukin-2 on days 1, 3, and 5 of weeks 2-6. Patients are assessed for response approximately 2 months after initiating therapy. Patients with stable or responding disease undergo a second course; those who continue to respond may receive additional therapy provided toxicity is limited. Patients are followed for survival. PROJECTED ACCRUAL: 14 patients will be entered.

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin
Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa
Intervention Type
Procedure
Intervention Name(s)
conventional surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven renal cell cancer that is metastatic No greater than 50% estimated hepatic replacement by tumor on CT or MRI No symptomatic involvement of the CNS or a major nerve Measurable disease required Ineligible for treatment with low-dose interleukin-2 on another CMC protocol PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50%-100% Life expectancy: More than 3 months Hematopoietic: No coagulopathy (i.e., platelet count less than 80,000/mm3) Hepatic: AST and ALT no greater than 5 times normal Renal: Creatinine less than 4.0 mg/dL Cardiovascular: No symptomatic angina No untreated coronary artery disease No refractory arrhythmia No abnormal left ventricular function Pulmonary: No dyspnea on minimal exertion Other: No site of ongoing bleeding No systemic infection No HIV antibody No HBsAg No requirement for steroids No psychiatric disease that precludes informed consent or protocol treatment No second malignancy except: Basal cell skin carcinoma Carcinoma in situ of the cervix Not pregnant or nursing Effective contraception required of fertile women PRIOR CONCURRENT THERAPY: Biologic therapy No prior interleukin-2 Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other At least 28 days since prior treatment for renal cell cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard L. White, MD
Organizational Affiliation
Blumenthal Cancer Center at Carolinas Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Blumenthal Cancer Center at Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232-2861
Country
United States

12. IPD Sharing Statement

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Interferon Alfa and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

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