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

Blumenthal Cancer Center at Carolinas Medical Center

Status and phase: Unknown; Phase 2

Conditions: Kidney Cancer

Treatments: Biological: aldesleukin; Biological: recombinant interferon alfa; Procedure: conventional surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00002847

CDR0000065086

NCI-V96-1039

CMC-09-95-14B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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