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Sponsored by: |
Weill Medical College of Cornell University |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003656 |
RATIONALE: Tretinoin may help kidney cancer cells develop into normal cells. Interferon alfa may interfere with the growth of cancer cells.
PURPOSE: Phase II trial to study the effectiveness of liposomal tretinoin plus interferon alfa in treating patients who have metastatic kidney cancer.
Condition | Intervention | Phase |
---|---|---|
Kidney Cancer |
Drug: recombinant interferon alfa Drug: tretinoin liposome |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Atragen and Interferon Alfa-2b in Patients With Advanced Renal Cell Carcinoma |
Estimated Enrollment: | 43 |
Study Start Date: | January 1999 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of tretinoin liposome with concurrent individual dose escalation of interferon alfa-2b. (Phase I closed to accrual as of 9/24/03.)
Patients receive tretinoin liposome IV over 30 minutes once weekly and interferon alfa-2b subcutaneously on five consecutive days (M-F) for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tretinoin liposome until the maximum tolerated dose (MTD) has been determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined additional patients are accrued and treated at that dose. (Phase I closed to accrual as of 9/24/03.)
During the first 3 weeks of the study, patients receive interferon alfa-2b at weekly dose escalations. After week 3, patients continue at the highest acceptable dose level of interferon alfa-2b for the remainder of the study. (Phase I closed to accrual as of 9/24/03.)
Patients are followed at 30 days after the last treatment.
PROJECTED ACCRUAL: A total of 3-18 patients will be accrued into the phase I portion of this study (Phase I closed to accrual as of 9/24/03). A total of 14-25 patients will be accrued into the phase II portion of this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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, New York | |
Herbert Irving Comprehensive Cancer Center at Columbia University | |
New York, New York, United States, 10032 | |
New York Weill Cornell Cancer Center at Cornell University | |
New York, New York, United States, 10021 |
Study Chair: | David M. Nanus, MD | Weill Medical College of Cornell University |
Study ID Numbers: | CDR0000066748, NYWCCC-0498-209, NCI-V98-1490 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003656 |
Health Authority: | United States: Federal Government |
stage IV renal cell cancer recurrent renal cell cancer |
Interferon-alpha Interferon Type I, Recombinant Interferons Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Recurrence Carcinoma Urologic Diseases |
Kidney Neoplasms Carcinoma, Renal Cell Tretinoin Kidney Diseases Interferon Alfa-2a Adenocarcinoma Interferon Alfa-2b Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Antiviral Agents Angiogenesis Inhibitors |
Pharmacologic Actions Keratolytic Agents Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Dermatologic Agents |