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

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ClinicalTrials.gov Identifier: NCT00002846
Recruitment Status : Unknown
Verified December 2003 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : December 19, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Brief 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.


Condition or disease Intervention/treatment Phase
Kidney Cancer Biological: aldesleukin Procedure: conventional surgery Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Primary Purpose: Treatment
Official Title: TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH LOW-DOSE INTRAVENOUS RECOMBINANT INTERLEUKIN-2
Study Start Date : September 1995

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer
Drug Information available for: Aldesleukin





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00002846     History of Changes
Other Study ID Numbers: CDR0000065085
CMC-09-95-15B
NCI-V96-1038
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: December 2003

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

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