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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


Phase 3
18 Years
N/A
Not Enrolling
Female
Melanoma (Skin)

Thank you

Trial Information

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.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically documented malignant melanoma in node(s) meeting
one or more of the following criteria: 1 or more lymph nodes found to contain metastatic
melanoma with gross evidence of extracapsular nodal extension Nodal recurrence at the site
of previous lymphadenectomy All gross cancer removed with negative margins Prior node
biopsy allowed if complete nodal dissection performed Parotid involvement outside a node
allowed No distant metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy:
Not specified Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 125,000/mm3
Hematocrit at least 33% Hepatic: AST no greater than 2 times upper limit of normal (ULN)
LDH no greater than 2 times ULN Alkaline phosphatase no greater than 2 times ULN Bilirubin
no greater than 2 times ULN If LDH or alkaline phosphatase are above normal, CT or MRI of
liver required Renal: Creatinine no greater than 1.8 mg/dL BUN no greater than 33 mg/dL
Other: Not pregnant or nursing Fertile patients must use effective contraception No other
prior or concurrent malignancies within 2 years, except any carcinoma in situ, lobular
carcinoma of the breast in situ, carcinoma in situ of the cervix, atypical melanocytic
hyperplasia or Clark I melanoma in situ, or basal or squamous cell skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior interferon Chemotherapy: Not
specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the head
and neck, axillary, or inguinal areas Surgery: See Disease Characteristics Recovered from
prior surgery

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Maury M. Rosenstein, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UPMC Cancer Center at UPMC St. Margaret

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000066472

NCT ID:

NCT00003444

Start Date:

October 1998

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

Name

Location

Emory University Hospital - AtlantaAtlanta, Georgia  30322
Ireland Cancer CenterCleveland, Ohio  44106-5065
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
New England Medical Center HospitalBoston, Massachusetts  02111
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
CCOP - Northern New JerseyHackensack, New Jersey  07601
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - Geisinger Clinical and Medical CenterDanville, Pennsylvania  17822-2001
Medical College of WisconsinMilwaukee, Wisconsin  53226
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - AlbanyAlbany, New York  12208
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
Veterans Affairs Medical Center - Chicago (Lakeside)Chicago, Illinois  60611
Hackensack University Medical CenterHackensack, New Jersey  07601
Riverview Medical CenterRed Bank, New Jersey  07701
UPMC St. MargaretPittsburgh, Pennsylvania  15215