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Interleukin-2 in Treating Patients With Metastatic or Recurrent Kidney Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2003 by National Cancer Institute (NCI).   Recruitment status was  Active, not recruiting

First Received on November 1, 1999.   Last Updated on 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: Primary Purpose: Treatment
Official Title: TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH LOW-DOSE INTRAVENOUS RECOMBINANT INTERLEUKIN-2

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Cancer
Drug Information available for: Interleukin-2 Aldesleukin
U.S. FDA Resources

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:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00002846     History of Changes
Other Study ID Numbers: CDR0000065085, CMC-09-95-15B, NCI-V96-1038
Study First Received: November 1, 1999
Last Updated: February 6, 2009
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:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Aldesleukin
Interleukin-2
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on February 12, 2012



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