Full Text View
Tabular View
No Study Results Posted
Related Studies
Interleukin-2 in Treating Patients With Metastatic or Recurrent Kidney Cancer
This study is ongoing, but not recruiting participants.
Study NCT00002846   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 NCT00002846 on ClinicalTrials.gov Archive Site
 
 
 
Interleukin-2 in Treating Patients With Metastatic or Recurrent Kidney Cancer
TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH LOW-DOSE INTRAVENOUS RECOMBINANT INTERLEUKIN-2

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.

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.

Phase II
Interventional
Treatment
Kidney Cancer
  • Biological: aldesleukin
  • 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 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002846
 
CDR0000065085, CMC-09-95-15B, NCI-V96-1038
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