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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: | NCT00002847 |
RATIONALE: Biological therapies use different ways to stimulate the immune system to try to stop cancer cells from growing. Combining interferon alfa and interleukin-2 may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of interferon alfa and interleukin-2 in treating patients with metastatic kidney cancer.
Condition | Intervention | Phase |
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Kidney Cancer |
Biological: aldesleukin Biological: recombinant interferon alfa Procedure: conventional surgery |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH SUBCUTANEOUS RECOMBINANT INTERLEUKIN-2 AND INTERFERON ALPHA |
Estimated Enrollment: | 14 |
Study Start Date: | September 1995 |
OBJECTIVES:
OUTLINE: Patients undergo nephrectomy if the diseased kidney makes up the bulk of the tumor burden.
All patients receive subcutaneous interferon alfa on day 1 and interleukin-2 on days 3-5 of week 1, followed by reduced doses of interferon alfa and interleukin-2 on days 1, 3, and 5 of weeks 2-6. Patients are assessed for response approximately 2 months after initiating therapy. Patients with stable or responding disease undergo a second course; those who continue to respond may receive additional therapy provided toxicity is limited.
Patients are followed for survival.
PROJECTED ACCRUAL: 14 patients will be entered.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven renal cell cancer that is metastatic
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
No second malignancy except:
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: | CDR0000065086, CMC-09-95-14B, NCI-V96-1039 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00002847 History of Changes |
Health Authority: | United States: Federal Government |
stage IV renal cell cancer recurrent renal cell cancer |
Urinary Tract Neoplasm Anti-Infective Agents Interferon Type I, Recombinant Immunologic Factors Urogenital Neoplasms Urologic Neoplasms Renal Cancer Anti-Retroviral Agents Urologic Diseases Kidney Neoplasms Kidney Diseases Analgesics Interferon-alpha Kidney Cancer |
Anti-HIV Agents Interferons Antiviral Agents Angiogenesis Inhibitors Recurrence Carcinoma Aldesleukin Interleukin-2 Analgesics, Non-Narcotic Carcinoma, Renal Cell Peripheral Nervous System Agents Adenocarcinoma Interferon Alfa-2a Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Interferon Type I, Recombinant Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Neoplasms by Site Anti-Retroviral Agents Urologic Diseases Sensory System Agents Kidney Neoplasms Therapeutic Uses Analgesics Growth Inhibitors |
Angiogenesis Modulating Agents Kidney Diseases Interferon-alpha Anti-HIV Agents Neoplasms by Histologic Type Growth Substances Interferons Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Carcinoma Neoplasms Aldesleukin Analgesics, Non-Narcotic Interleukin-2 |