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
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|
- 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|
|Official Title:||TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH LOW-DOSE INTRAVENOUS RECOMBINANT INTERLEUKIN-2|
|Study Start Date :||September 1995|
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
|United States, North Carolina|
|Carolinas Medical Center|
|Charlotte, North Carolina, United States, 28232-2861|
|Study Chair:||Richard L. White, MD||Blumenthal Cancer Center at Carolinas Medical Center|