High-Dose Interferon Alfa in Treating Patients With Stage II or StageIII Melanoma

Withdrawn before enrolling · Phase 3

Conditions studied: Melanoma (Skin)

In brief

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.

Key facts

Study ID

NCT00447356

Run by

Hackensack Meridian Health

People needed

0

Starts

2000-01-01

Last updated by the study team

2013-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed primary melanoma of cutaneous origin
• Stage II (T3 N0 M0 1.5-4.0mm Breslow depth
• Clinically negative regional lymph node pathologic status unkown OR
• Histologically negative regional lymph nodes
• Stage III (T4 N0 M0)
• Greater than 4.0mm Breslow depth OR
• Stage III (T1-4 N1)
• One lymph node positive microscopically
• Patients must meet at least 1 of the following criteria
• T2b N0 primary melanoma 1.01-2.0mm with ulceration, node negative
• T3a-b N0 primary melanoma 2.01-4.0mm with and without ulceration, node negative
• T4a-b N0 primary melanoma > 4.0mm with and without ulceration, node negative
• T1aN1a-2a (microscopic)-primary melanoma of any thickness with microscopically positive lymph node (any number)
• Note EORTC patients who are node negative T2 or T3 are ineligible
• Patients with 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 the study within 84 days of wide excision
• No clinical, radiological/laboratory, or pathological evidence of incompletely resected melanoma or any distant metastatic disease
• No clinically palpable lymphadenopathy
• Age:
• 18 and over
• Performance Status:
• ECOG 0-1
• Life expectancy:
• Not specified Hematopoietic
• WBC at least 3,000/mm\^3

You may not qualify if…

• Biologic Therapy:
• No prior immunotherapy including tumor vaccines, interferon, interleukins,levamisole, or other biologic response modifers for melanoma Chemotherapy
• No prior or concurrent chemotherapy Endocrine Therapy
• No concurrent systemic corticosteriods including oral steriods (i.e., prednisone, dexamethasone), topical steroid creams or ointments, or any steriod-containing inhalers.
• Radiotherapy:
• No Prior or concurrent radiotherapy
• Surgery:
• See Disease characteristics
• Other:
• No other concurrent immunosuppressive medications
• No other history of invasive melanoma
• No autoimmune disorders or conditions of immunosuppression
• No other concurrent or prior malignancies within past 5 years
• Cancer in situ
• Lobular carcinoma in situ of 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

Where it is running

• The Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States

Full record on ClinicalTrials.gov

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