Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. It is not yet known whether treatment with interferon alfa is more effective than observation alone for stage II or stage III melanoma that has been completely removed surgically.

PURPOSE: This randomized phase III trial is studying high dose interferon alfa to see how well it works compared to observation only in treating patients with stage II or stage III melanoma that has been completely removed by surgery.

Further Study Information

OBJECTIVES:

• Compare the effect of high-dose interferon alfa-2b treatment on the relapse-free survival of patients with stage II or III resected malignant melanoma.

• Compare the effect of this treatment regimen on overall survival of these patients.

• Assess the toxicity of this treatment in these patients.

• Compare the effect of treatment on quality-adjusted survival.

OUTLINE: This is a randomized study. Patients are stratified by pathologic lymph node status (known vs unknown by sentinel lymph node procedure vs by elective lymph node dissection vs by no lymphadenectomy), Breslow depth (< 1.0 mm [lymph node positive patients only] vs 1.01-2.0 mm vs 2.01-4.0 mm vs > 4.0 mm), ulceration of the primary lesion (yes vs no vs unknown), and disease stage (lymph node positive [N_1a, N_2a microscopic] vs lymph node negative [N_0]). Patients are randomized into one of two treatment arms.

• Arm I: Patients undergo observation for 4 weeks.

• Arm II: Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.

Quality of life is assessed before treatment, at day 22, every 3 months for 2 years, and then every 6 months for 3 years.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,420 patients will be accrued for this study over 5 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed primary melanoma of cutaneous origin

• Stage II (T3 N0 M0 1.5-4.0 mm Breslow depth)

• Clinically negative regional lymph node pathologic status unknown OR

• Histologically negative regional lymph nodes

• Stage III (T4 N0 M0)

• Greater than 4.0 mm Breslow depth OR

• Stage III (T1-4 N1)

• One lymph node positive microscopically

• Patients must meet at least 1 of the following criteria:

• T_2b N_0 - primary melanoma 1.01-2.0 mm with ulceration, node negative

• T_3a-b N_0 - primary melanoma 2.01-4.0 mm with and without ulceration, node negative

• T_4a-b N_0 - primary melanoma > 4.0 mm with or without ulceration, node negative

• T_1-a N_1a-2a (microscopic) - primary melanoma of any thickness with microscopically positive lymph node (any number)

• Patients with a positive sentinel node should undergo complete lymphadenectomy of the nodal basin prior to study

• Must complete all primary therapy (wide excision with or without lymphadenectomy) and be randomized in this study within 84 days of wide excision

• Must have undergone an adequate wide excision of the primary lesion

• No clinical, radiological/laboratory, or pathological evidence of incompletely resected melanoma or any distant metastatic disease

• No clinically palpable lymphadenopathy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm^3

• Platelet count at least 125,000/mm^3

• Hematocrit at least 30%

Hepatic:

• Bilirubin no greater than 2 times upper limit of normal (ULN)

• AST, LDH, and alkaline phosphatase no greater than 2 times ULN

• If lactate dehydrogenase or alkaline phosphatase is above normal, a contrast-enhanced CT scan or MRI of the liver is required to document the absence of tumor

Renal:

• BUN no greater than 33 mg/dL OR

• Creatinine no greater than 1.8 mg/dL

Cardiovascular:

• No history of active ischemic heart disease

• No cerebrovascular disease

• No congestive heart failure (New York Heart Association class III or IV heart disease)

Other:

• No other history of invasive melanoma

• No autoimmune disorders or conditions of immunosuppression

• No other concurrent or prior malignancies within the past 5 years except:

• Cancer in situ

• Lobular carcinoma in situ of the breast

• Carcinoma in situ of the cervix

• Atypical melanocytic hyperplasia or Clark 1 melanoma in situ

• Basal or squamous cell skin cancer

• No evidence of organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that would preclude study participation

• No other significant medical or surgical condition, or any medication or treatment regimens, that would interfere with study participation

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 6 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior immunotherapy including tumor vaccines, interferon, interleukins, levamisole, or other biologic response modifiers for melanoma

Chemotherapy:

• No prior or concurrent chemotherapy

Endocrine therapy:

• No concurrent systemic corticosteroids including oral steroids (i.e., prednisone, dexamethasone), topical steroid creams or ointments, or any steroid-containing inhalers

Radiotherapy:

• No prior or concurrent radiotherapy

Surgery:

• See Disease Characteristics

Other:

• No other concurrent immunosuppressive medications

Trial Contact Information

Trial Lead Organizations/Sponsors

Eastern Cooperative Oncology Group

Sanjiv S. Agarwala

Study Chair

John Munn Kirkwood

Lawrence E. Flaherty

Study Chair

William Edgar Carson

Study Chair

Michael Smylie

Study Chair

Alberto S. Pappo

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00003641
Information obtained from ClinicalTrials.gov on December 03, 2012

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