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| Sponsored by: |
Blumenthal Cancer Center at Carolinas Medical Center |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00080977 |
Purpose
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 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.
Eligibility| 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
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000357581, CMC-10-01-01AH |
| Study First Received: | April 7, 2004 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00080977 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent renal cell cancer stage IV renal cell cancer |
|
Urinary Tract Neoplasm Kidney Cancer Anti-HIV Agents Urogenital Neoplasms Urologic Neoplasms Antiviral Agents Recurrence Carcinoma Aldesleukin Renal Cancer Anti-Retroviral Agents |
Urologic Diseases Analgesics, Non-Narcotic Interleukin-2 Kidney Neoplasms Carcinoma, Renal Cell Peripheral Nervous System Agents Analgesics Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |
|
Anti-Infective Agents Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Neoplasms by Site Urologic Diseases Anti-Retroviral Agents Kidney Neoplasms Sensory System Agents Therapeutic Uses Kidney Diseases Analgesics Neoplasms by Histologic Type |
Anti-HIV Agents Antiviral Agents Pharmacologic Actions Carcinoma Neoplasms Aldesleukin Interleukin-2 Analgesics, Non-Narcotic Carcinoma, Renal Cell Peripheral Nervous System Agents Adenocarcinoma Central Nervous System Agents Neoplasms, Glandular and Epithelial |