Phase II Trial of Atragen and Interferon Alfa-2b in Patients With Advanced Renal Cell Carcinoma
- 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
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.
Masking: Open Label, Primary Purpose: Treatment
Response as measured by CT, bone scans, and clinical progression at 8 weeks after first dose
David M. Nanus, MD
Weill Medical College of Cornell University
United States: Federal Government
|Herbert Irving Comprehensive Cancer Center at Columbia University||New York, New York 10032|
|New York Weill Cornell Cancer Center at Cornell University||New York, New York 10021|