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

Kidney Cancer Clinical Trial

Official title:

TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH SUBCUTANEOUS RECOMBINANT INTERLEUKIN-2 AND INTERFERON ALPHA

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00002847
• Other study ID #: CDR0000065086
• Secondary ID: CMC-09-95-14BNCI
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: December 18, 2013
• Start date: September 1995

Study information

• Verified date: December 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Biological:
• aldesleukin

• recombinant interferon alfa

Procedure:
• conventional surgery

Locations

Country	Name	City	State
United States	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Blumenthal Cancer Center at Carolinas Medical Center

Country where clinical trial is conducted

United States,