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

NCT ID: NCT00002847

Last Updated: 2013-12-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-09-30

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.

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancer; recurrent renal cell cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

aldesleukin

Intervention Type: BIOLOGICAL

recombinant interferon alfa

Intervention Type: BIOLOGICAL

conventional surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

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

Sponsors

Blumenthal Cancer Center at Carolinas Medical Center

OTHER

Sponsor Role: lead

Principal Investigators

Richard L. White, MD

Role: STUDY_CHAIR

Blumenthal Cancer Center at Carolinas Medical Center

Locations

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, United States

Countries

United States

Other Identifiers

CMC-09-95-14B

Identifier Type: -

Identifier Source: secondary_id

NCI-V96-1039

Identifier Type: -

Identifier Source: secondary_id

CDR0000065086

Identifier Type: -

Identifier Source: org_study_id