POST-OPERATIVE ADJUVANT INTERFERON-ALFA-2B (INTRON-A) TREATMENT AFTER RESECTION OF THICK PRIMARY MELANOMA AND/OR REGIONAL LYMPHNODE METASTASES 'INTERMEDIATE-HIGH DOSE' VS INTERMEDIATE-LOW DOSE' IFN-ALFA VS OBSERVATION: A 3-ARM MULTICENTER RANDOMIZED PHASE III TRIAL
16 Years
75 Years
Both
Melanoma (Skin)
Trial Information
POST-OPERATIVE ADJUVANT INTERFERON-ALFA-2B (INTRON-A) TREATMENT AFTER RESECTION OF THICK PRIMARY MELANOMA AND/OR REGIONAL LYMPHNODE METASTASES 'INTERMEDIATE-HIGH DOSE' VS INTERMEDIATE-LOW DOSE' IFN-ALFA VS OBSERVATION: A 3-ARM MULTICENTER RANDOMIZED PHASE III TRIAL
OBJECTIVES: I. Evaluate the time to distant metastasis, death due to melanoma, and overall
survival in patients with high-risk stage III melanoma treated with 10 MU of interferon alfa
(IFN-A) for 4 weeks followed by 1 year of IFN-A at 10 MU three times per week vs. 2 years of
IFN-A at 5 MU three times per week vs. observation alone. II. Assess the toxicity associated
with IFN-A. III. Compare the quality of life, costs, and compliance associated with each
treatment regimen.
OUTLINE: Randomized study. Following definitive surgical resection, patients are randomly
assigned in a 2:2:1 ratio to Arms A, B, and C, respectively. Arm A: Biological Response
Modifier Therapy. Interferon alfa-2b (Schering), IFN-A, NSC-377523. Higher dose. Arm B:
Biological Response Modifier Therapy. IFN-A. Lower dose. Arm C: Control. Observation.
PROJECTED ACCRUAL: A total of 1,000 patients will be entered over approximately 4 years in
this multicenter study.
Inclusion Criteria
DISEASE CHARACTERISTICS: Cutaneous melanoma in one of the following categories: T4, N0, M0
Deep primary tumor with Breslow depth greater than 4.0 cm Tx, N1, M0 Primary tumor with
regional lymph node metastases found at lymphadenectomy but clinically undetectable Tx,
N2, M0 Clinically apparent regional lymph node metastases (synchronous or metachronous)
confirmed by lymphadenectomy Definitive surgical resection and lymphadenectomy with
pathologically confirmed adequate surgical margins required Minimum 2 cm margin for
primary lesions with Breslow depth greater than 2 mm Distal interphalangeal amputation
required for subungual melanomas No primary melanoma originating apart from the skin No
multiple in transit metastases in an extremity No lymph node involvement outside the
operative area resected by radical neck, axillary lymph node, or ilioinguinal dissection
PATIENT CHARACTERISTICS: Age: 16 to 75 Performance status: ECOG 0 or 1 Hematopoietic: WBC
at least 4,000 Platelets at least 125,000 Hemoglobin at least 9.8 g/dL (6.1 mmol/L)
Hepatic: Bilirubin no greater than 2 times normal AST no greater than 2 times normal
Renal: Creatinine no greater than 1.6 mg/dL (140 micromoles/L) Cardiovascular: No
ventricular or supraventricular arrhythmia requiring treatment No congestive heart failure
(NYHA class 3/4 status) Other: No uncontrolled infection No requirement for ongoing
steroids, NSAIDs, or other immunomodulators No organic brain syndrome or significant
impairment of basal cognitive function No psychiatric disorder that would preclude study
participation or would be exacerbated by study therapy (e.g., depression) No second
malignancy except: In situ cervical cancer Nonmelanomatous skin cancer No pregnant or
nursing women
PRIOR CONCURRENT THERAPY: No prior treatment on this protocol for patients with recurrent
melanoma at regional lymph nodes No preoperative infusion or perfusion therapy Biologic
therapy: No prior adjuvant immunotherapy Chemotherapy: No prior adjuvant systemic
chemotherapy No prior anthracyclines Endocrine therapy: Not specified Radiotherapy: No
prior adjuvant radiotherapy Surgery: See Disease Characteristics
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Alexander M. M. Eggermont, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Authority:
United States: Federal Government
Study ID:
CDR0000064718
NCT ID:
NCT00002763
Start Date:
April 1996
Completion Date:
Related Keywords:
- Melanoma (Skin)
- stage III melanoma
- recurrent melanoma
- Melanoma
Name | Location |
|---|
