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Interleukin-2 in Treating Patients With Metastatic or Recurrent Kidney Cancer
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsor: Blumenthal Cancer Center at Carolinas Medical Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002846
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Biological: aldesleukin
Procedure: conventional surgery
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH LOW-DOSE INTRAVENOUS RECOMBINANT INTERLEUKIN-2

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 14
Study Start Date: September 1995
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002846

Locations
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Sponsors and Collaborators
Blumenthal Cancer Center at Carolinas Medical Center
Investigators
Study Chair: Richard L. White, MD Blumenthal Cancer Center at Carolinas Medical Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000065085, CMC-09-95-15B, NCI-V96-1038
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00002846     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:
Anti-Infective Agents
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Urologic Neoplasms
Neoplasms by Site
Urologic Diseases
Anti-Retroviral Agents
Kidney Neoplasms
Sensory System Agents
Therapeutic Uses
Kidney Diseases
Analgesics
Neoplasms by Histologic Type
Anti-HIV Agents
Antiviral Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Aldesleukin
Interleukin-2
Analgesics, Non-Narcotic
Carcinoma, Renal Cell
Peripheral Nervous System Agents
Adenocarcinoma
Central Nervous System Agents
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009