Non-melanomatous Skin Cancer Clinical Trial
Official title:
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
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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00103246 -
Photodynamic Therapy Using Silicon Phthalocyanine 4 in Treating Patients With Actinic Keratosis, Bowen's Disease, Skin Cancer, or Stage I or Stage II Mycosis Fungoides
|
Phase 1 | |
| Active, not recruiting |
NCT00391300 -
Bioelectric Field Imaging in Diagnosing Melanoma and Other Skin Cancers in Patients With Skin Lesions
|
Phase 1 | |
| Completed |
NCT00066872 -
Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer
|
Phase 3 | |
| Completed |
NCT00002963 -
Photodynamic Therapy in Treating Patients With Skin Cancer
|
Phase 2 | |
| Completed |
NCT00021294 -
Eflornithine With or Without Triamcinolone in Preventing Nonmelanoma Skin Cancer in Patients With Actinic Keratosis
|
Phase 2 | |
| Completed |
NCT00003611 -
Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation
|
N/A | |
| Terminated |
NCT00663910 -
Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer
|
Phase 0 | |
| Recruiting |
NCT00295906 -
Computer-Based Continuing Education for Doctors in Examination and Counseling of Patients on Skin Cancer or Weight Control
|
N/A | |
| Completed |
NCT00025012 -
Isotretinoin in Preventing Skin Cancer
|
N/A | |
| Completed |
NCT00021125 -
Radiation Therapy in Treating Patients With Head and Neck Cancer
|
Phase 3 | |
| Completed |
NCT00601640 -
Eflornithine and/or Diclofenac in Treating Patients With Sun-Damaged Skin
|
Phase 2 | |
| Completed |
NCT00079300 -
Imiquimod Cream in Treating Patients With Basal Cell Skin Cancer
|
Phase 1 | |
| Completed |
NCT00017485 -
Photodynamic Therapy in Treating Patients With Basal Cell Skin Cancer
|
Phase 1 | |
| Recruiting |
NCT00747903 -
Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer
|
Phase 2 | |
| Terminated |
NCT00899132 -
Studying a Tumor Marker for Testicular Cancer, Skin Cancer, Small Intestine Cancer, and Pancreatic Cancer
|
N/A | |
| Completed |
NCT00099112 -
Effect of Solar-Simulated Ultraviolet Radiation on Gene Expression in Unprotected and Sunscreen-Protected Skin of Healthy Adults With Fitzpatrick Skin Type II
|
N/A | |
| Completed |
NCT00644384 -
Acitretin in Preventing Skin Cancer in Patients at High Risk for Skin Cancer
|
N/A | |
| Completed |
NCT00023621 -
Celecoxib in Preventing Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome
|
Phase 2 | |
| Completed |
NCT00002975 -
Photodynamic Therapy in Treating Patients With Skin Cancer
|
Phase 2 | |
| Completed |
NCT00295958 -
LMB-2 Immunotoxin and Vaccine Therapy in Treating Patients With Metastatic Melanoma That Cannot Be Removed By Surgery
|
Phase 2 |