Non-melanomatous Skin Cancer Clinical Trial
Official title:
Chemoprevention of Skin Cancers With DFMO: A Controlled, Randomized Clinical Trial
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
development or recurrence of cancer. The use of eflornithine may be an effective way to
prevent the recurrence of or further development of skin cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of eflornithine in
preventing skin cancer in patients who have previously received treatment for early stage
skin cancer.
OBJECTIVES: I. Compare the rate of new skin cancer in patients with previously treated stage
0, I, or II basal or squamous cell skin cancer treated with eflornithine (DFMO) vs placebo.
II. Determine whether inhibition of TPA-induced ornithine decarboxylase activity serves as an
intermediary marker for response to DFMO in these patients. III. Determine whether inhibition
of skin polyamine levels serves as an intermediary marker for response to DFMO in these
patients. IV. Assess the long term toxic effects of this treatment in these patients.
OUTLINE: This a randomized, double blind, placebo controlled, multicenter study. Patients
receive oral placebo daily for the first 4 weeks. Patients who comply with taking 80-100% of
placebo are randomized to one of two treatment arms. Arm I: Patients receive oral
eflornithine (DFMO) daily. Arm II: Patients receive an oral placebo daily. Treatment
continues for 3-5 years in the absence of unacceptable toxicity. Patients who develop skin
cancer during study undergo surgical excision and continue treatment on the arm to which they
were originally randomized. Patients are followed every 6 months through year 5.
PROJECTED ACCRUAL: A total of 334 patients (167 per arm) will be accrued for this study over
2 years.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT00423397 -
Gefitinib and PEG-Interferon Alfa-2a in Treating Patients With Unresectable or Metastatic Skin Cancer
|
Phase 1/Phase 2 | |
| 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 |