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High-Dose Intravenous Interleukin-2 in Treating Patients With Metastatic Renal Cell Carcinoma (Kidney Cancer) That Has Not Responded to Previous Low-Dose Intravenous or Subcutaneous Interleukin-2

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2005 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: April 7, 2004
Last updated: December 18, 2013
Last verified: June 2005

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill renal cell carcinoma (kidney cancer) cells.

PURPOSE: This phase II trial is studying how well high-dose intravenous interleukin-2 works in treating patients with metastatic renal cell carcinoma that has not responded to previous low-dose intravenous or subcutaneous interleukin-2.

Condition Intervention Phase
Kidney Cancer
Biological: aldesleukin
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Treatment of Patients With Metastatic Renal Cell Carcinoma Who Have Failed Low Dose Intensity Interleukin-2 With High-Dose Intravenous Recombinant Interleukin-2

Resource links provided by NLM:

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

Study Start Date: June 1998
Detailed Description:


  • Determine the response rate (complete, partial, and minor) in patients with metastatic renal cell carcinoma who failed prior low-dose intravenous or subcutaneous interleukin-2 (IL-2) when treated with high-dose intravenous IL-2.
  • Determine the overall survival, disease-free survival, and time to progression in patients treated with this drug.
  • Determine the toxicity of this drug in these patients.

OUTLINE: This is a pilot study.

Patients receive high-dose interleukin-2 IV every 8 hours for 15 doses followed 7-10 days later by another 15 doses (course 1).

Patients are assesed for response 2 months after initiation of treatment. Patients with responding or stable disease receive a second course of therapy. Patients with an ongoing response receive subsequent courses of treatment in the absence of unacceptable toxicity.

Patients are followed every 6 months for survival.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed renal cell carcinoma

    • Metastatic disease
    • No pure papillary or sarcomatoid variants
  • Measurable disease
  • Failed prior subcutaneous OR intravenous (dose ≤ 50,000 IU/kg/day) interleukin-2

    • Documented disease progression
  • No estimated hepatic replacement by tumor > 25% by CT scan or MRI
  • No tumor involving the CNS or a major nerve



  • 18 and over

Performance status

  • Karnofsky 80-100%

Life expectancy

  • More than 3 months


  • Platelet count ≥ 80,000/mm^3
  • No sites of ongoing bleeding


  • See Disease Characteristics
  • Bilirubin ≤ 1.4 mg/dL
  • AST and ALT ≤ 3 times normal
  • PT or PTT INR ≤ 1.2
  • Hepatitis B surface antigen negative
  • Hepatitis C virus negative
  • No coagulation disorders


  • Creatinine ≤ 1.6 mg/dL


  • No ongoing ischemia*
  • No cardiac dysfunction*
  • No abnormal ejection fraction* NOTE: *A cardiac stress test is indicated for all patients ≥ 50 years of age and for any patient with possible cardiac disease as suggested by history, physical exam, or electrocardiogram


  • FEV_1 ≤ 65% of predicted*
  • Vital capacity ≤ 65% of predicted* NOTE: *Pulmonary function tests are to be performed on any patient with a significant smoking history or suspected pulmonary disease either by history, physical exam, or radiograph


  • HIV negative
  • No AIDS
  • No systemic infections
  • No other malignancy except carcinoma in situ
  • No psychiatric illness that would preclude study participation or compliance
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy

  • See Disease Characteristics


  • Not specified

Endocrine therapy

  • No concurrent steroids


  • Not specified


  • Not specified


  • More than 28 days since other prior treatment for renal cell cancer
  • No concurrent immunosuppressive agents
  Contacts and Locations
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Please refer to this study by its identifier: NCT00080977

United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Sponsors and Collaborators
Blumenthal Cancer Center at Carolinas Medical Center
Study Chair: Richard L. White, MD Blumenthal Cancer Center at Carolinas Medical Center
  More Information Identifier: NCT00080977     History of Changes
Other Study ID Numbers: CDR0000357581
Study First Received: April 7, 2004
Last Updated: December 18, 2013

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

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs processed this record on April 26, 2017