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Phase II Trial of Atragen and Interferon Alfa-2b in Patients With Advanced Renal Cell Carcinoma (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.
  • Biological: recombinant interferon alfa
    • Drug: tretinoin liposome
      Ages eligible for Study
      18 Years to 120 Years
      Genders eligible for Study
      Accepts Healthy Volunteers

      - Determine the response in patients with metastatic renal cell carcinoma treated with tretinoin liposome and interferon alfa-2b.

      - Determine the toxicity of this regimen in these patients.

      - Study retinoic acid receptor expression on tissue obtained from selected patients who have tumor biopsies.

      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.

      2 locations

      United States (2)
      • New York Weill Cornell Cancer Center at Cornell University
        Not specified
        New York, New York, United States, 10021
      • Herbert Irving Comprehensive Cancer Center at Columbia University
        Not specified
        New York, New York, United States, 10032
      31 December, 1998
      05 November, 2017
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