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A RANDOMISED STUDY OF OBSERVATION VERSUS ADJUVANT LOW DOSE EXTENDED DURATION INTERFERON ALPHA-2A IN COMPLETELY RESECTED HIGH RISK MALIGNANT MELANOMA


Phase 3
N/A
N/A
Open (Enrolling)
Both
Melanoma (Skin)

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Trial Information

A RANDOMISED STUDY OF OBSERVATION VERSUS ADJUVANT LOW DOSE EXTENDED DURATION INTERFERON ALPHA-2A IN COMPLETELY RESECTED HIGH RISK MALIGNANT MELANOMA


OBJECTIVES: I. Determine the effects of adjuvant low-dose extended-duration interferon alfa
on disease-free and overall survival in patients with completely resected malignant melanoma
at high risk of recurrence. II. Determine any correlation between patient age or sex and the
effects of interferon therapy on disease-free and overall survival. III. Describe the toxic
effects of this treatment. IV. Evaluate the economic implications of implementing effective
interferon therapy in these patients.

OUTLINE: This is a randomized study. Patients will be stratified by age, sex, disease status
at entry, and participating institution. Patients are randomized to observation only or to
receive interferon alfa by subcutaneous injections 3 times weekly for 2 years, or until
disease progression or toxicity intervenes. Patients are followed monthly for 6 months,
quarterly for 18 months, and every 6 months thereafter.

PROJECTED ACCRUAL: A total of 1,000 patients will be entered over 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed malignant melanoma definitively resected
within 12 weeks prior to entry One of the following categories: Stage II disease (greater
than 4 mm Breslow thickness) Stage III disease (regional lymph node involvement) Recurrent
non-nodal superficial regional disease (local or in transit) Recurrent regional nodal
involvement

PATIENT CHARACTERISTICS: Able to tolerate interferon No second malignancy except
curatively treated: Carcinoma of the cervix Nonmelanomatous skin cancer No pregnant or
nursing women

PRIOR CONCURRENT THERAPY: No prior immunosuppressive therapy, including systemic steroids
No prior biologic therapy Recovered from surgery

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Barry W. Hancock, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Research Centre at Weston Park Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000065215

NCT ID:

NCT00002892

Start Date:

October 1995

Completion Date:

Related Keywords:

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

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