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Sponsored by: |
Blumenthal Cancer Center at Carolinas Medical Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00080977 |
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 |
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Kidney Cancer |
Drug: aldesleukin |
Phase II |
Study Type: | Interventional |
Study Design: | 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 |
Study Start Date: | June 1998 |
OBJECTIVES:
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 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed renal cell carcinoma
Failed prior subcutaneous OR intravenous (dose ≤ 50,000 IU/kg/day) interleukin-2
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, North Carolina | |
Blumenthal Cancer Center at Carolinas Medical Center | |
Charlotte, North Carolina, United States, 28232-2861 |
Study Chair: | Richard L. White, MD | Blumenthal Cancer Center at Carolinas Medical Center |
Study ID Numbers: | CDR0000357581, CMC-10-01-01AH |
Study First Received: | April 7, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00080977 |
Health Authority: | United States: Federal Government |
recurrent renal cell cancer stage IV renal cell cancer |
Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Recurrence Carcinoma Aldesleukin Urologic Diseases |
Interleukin-2 Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Neoplasms by Histologic Type Anti-HIV Agents Antineoplastic Agents Physiological Effects of Drugs Antiviral Agents Pharmacologic Actions Neoplasms |
Neoplasms by Site Anti-Retroviral Agents Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents |