Interleukin-2 in Treating Patients With Metastatic or Recurrent Kidney Cancer

Kidney Cancer Clinical Trial

Official title:

TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH LOW-DOSE INTRAVENOUS RECOMBINANT INTERLEUKIN-2

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00002846
• Other study ID #: CDR0000065085
• Secondary ID: CMC-09-95-15BNCI
• 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: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells.

PURPOSE: Phase II trial to study the effectiveness of low-dose interleukin-2 in treating patients with metastatic or recurrent kidney cancer.

Description:

OBJECTIVES:

• Assess the response rate and survival of patients with metastatic renal cell carcinoma treated with low-dose intravenous interleukin-2.

• Assess the toxicity associated with this treatment.

OUTLINE: Patients receive low-dose intravenous interleukin-2 every 8 hours for a maximum of 15 doses in week 1 and again in week 3. Stable and responding patients receive a second course beginning approximately 2 months after initiation of the first course. Responding patients may continue therapy every 2 months provided toxicity is limited.

Patients whose diseased kidney comprises the bulk of the tumor burden at entry undergo nephrectomy.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 14 patients will be accrued for this study.

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 confirmed renal cell carcinoma (RCC) that is metastatic or recurrent

• No central nervous system or major nerve involvement

• No more than 25% estimated hepatic replacement by tumor on CT or MRI

• Measurable disease required

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 80%-100%

Life expectancy:

• Greater than 3 months

Hematopoietic:

• Platelet count at least 80,000/mm3

Hepatic:

• Bilirubin normal

• AST and ALT no greater than 3 times normal

Renal:

• Creatinine normal

Cardiovascular:

• Stress cardiac exam normal (exam performed in patients aged 50 and older and in those with potential cardiac disease suggested by history, physical exam, or EKG)

Pulmonary:

• FEV1 and VC greater than 65% of predicted (tests performed in patients with significant smoking history and in those with potential pulmonary disease suggested by history, physical exam, or x-ray)

Other:

• No sites of ongoing bleeding

• No HIV antibody or AIDS

• No hepatitis B antigen

• No systemic infection

• No requirement for steroids

• No psychiatric disease that precludes informed consent or safe administration of immunotherapy

• No second malignancy except:

• Basal cell carcinoma

• In situ cervical cancer

• Other cancer provided all evaluable lesions are documented RCC

• No pregnant or nursing women

• Effective contraception required of fertile women

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior interleukin-2 therapy

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• At least 28 days since therapy for RCC

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Biological:
• aldesleukin

Procedure:
• conventional surgery

Locations

Country	Name	City	State
United States	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,