NCT00423397

Gefitinib and PEG-Interferon Alfa-2a in Treating Patients With Unresectable or Metastatic Skin Cancer

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PEG-interferon alfa-2a may interfere with the growth of tumor cells and slow the growth of skin cancer. Giving gefitinib together with PEG-interferon alfa-2a may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of PEG-interferon alfa-2a when given together with gefitinib and to see how well they work in treating patients with unresectable or metastatic skin cancer.

Detailed description

OBJECTIVES: * 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.

Conditions

• Non-melanomatous Skin Cancer

Interventions

Type	Name	Description
BIOLOGICAL	PEG-interferon alfa-2a
DRUG	gefitinib

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-01-01
• First posted: 2007-01-18
• Last updated: 2013-12-19

Locations

1 site across 1 country: United States