A Prospective Randomized Phase III Clinical Trial Assessing the Role of Post-Operative Radiotherapy Plus Adjuvant Interferon Alpha-2b in Patients With Cervical, Axillary, and Inguinal Nodal Metastasis From Cutaneous Melanoma
OBJECTIVES: I. Evaluate the effectiveness of postoperative hypofractionated radiotherapy in
combination with high dose interferon in preventing regional relapse in patients with
malignant melanoma with any number of nodes with clinical extracapsular extension or
previous nodal basin recurrence. II. Evaluate the effectiveness of this therapy in
prolonging relapse free and overall survival in this patient population. III. Evaluate the
toxicity of this therapy in this patient population.
OUTLINE: This is a randomized study. Patients are stratified according to prior nodal basin
recurrence, site of disease, and extracapsular extension. Following surgery, patients are
randomized to receive either interferon alfa-2b alone or five treatments of radiotherapy
followed by interferon alfa-2b. Patients receive radiotherapy 2 days a week for 2.5 weeks.
Patients receive interferon alfa-2b IV over 20 minutes daily for 5 days for a total of 28
days, followed by subcutaneous injections 3 times a week for 48 weeks. Patients are followed
every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter.
PROJECTED ACCRUAL: Approximately 167 patients will be accrued for this study within 3 years.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Maury M. Rosenstein, MD
Study Chair
UPMC Cancer Center at UPMC St. Margaret
United States: Food and Drug Administration
CDR0000066472
NCT00003444
October 1998
Name | Location |
---|---|
Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
New England Medical Center Hospital | Boston, Massachusetts 02111 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
CCOP - Duluth | Duluth, Minnesota 55805 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
CCOP - Geisinger Clinical and Medical Center | Danville, Pennsylvania 17822-2001 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
Veterans Affairs Medical Center - Albany | Albany, New York 12208 |
Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin 53295 |
Veterans Affairs Medical Center - Chicago (Lakeside) | Chicago, Illinois 60611 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Riverview Medical Center | Red Bank, New Jersey 07701 |
UPMC St. Margaret | Pittsburgh, Pennsylvania 15215 |