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Interferon Alfa and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
This study is ongoing, but not recruiting participants.
Study NCT00002847   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes

November 1, 1999
February 6, 2009
September 1995
 
 
 
Complete list of historical versions of study NCT00002847 on ClinicalTrials.gov Archive Site
 
 
 
Interferon Alfa and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH SUBCUTANEOUS RECOMBINANT INTERLEUKIN-2 AND INTERFERON ALPHA

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.

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.

Phase II
Interventional
Treatment
Kidney Cancer
  • Biological: aldesleukin
  • Biological: recombinant interferon alfa
  • Procedure: conventional surgery
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
14
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002847
 
CDR0000065086, CMC-09-95-14B, NCI-V96-1039
Blumenthal Cancer Center at Carolinas Medical Center
 
Study Chair: Richard L. White, MD Blumenthal Cancer Center at Carolinas Medical Center
National Cancer Institute (NCI)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP