A Phase I/II Pilot Study of Bioimmunotherapy With IRESSA (Gefitinib) and Pegylated Interferon Alpha-2a for Patients With Unresectable/Metastatic Squamous Cell Carcinoma of the Skin
- Determine the tolerability of gefitinib and PEG-interferon alfa-2a in patients with
unresectable or metastatic squamous cell carcinoma of the skin.
- Determine the response rate in patients treated with gefitinib for 1 month.
- Determine whether the addition of weekly PEG-interferon alfa-2a to ongoing gefitinib
improves response rate in these patients .
- Determine whether PEG-interferon alfa-2a exacerbates rash in patients who have been
treated with gefitinib for 1 month.
OUTLINE: This is a phase I, pilot, dose de-escalation study of PEG-interferon alfa-2a
followed by an open-label, phase II study.
- Phase I: Patients receive oral gefitinib alone once daily for 4 weeks. Beginning in
week 5, patients also receive PEG-interferon alfa-2a subcutaneously once weekly.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of patients receive de-escalating doses of PEG-interferon alfa-2a until a tolerable
dose is determined.
- Phase II: Patients receive gefitinib and PEG-interferon alfa-2a at the tolerable dose
determined in phase I.
PROJECTED ACCRUAL: A total of 16 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
William L. Read, MD
University of California, San Diego
United States: Federal Government
|Rebecca and John Moores UCSD Cancer Center||La Jolla, California 92093-0658|