High-Dose Interferon Alfa for Melanoma

Palo Alto (17 mi)

Overseen byAlberto S. Pappo, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: ECOG-ACRIN Cancer Research Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults over 18 with stage II or III melanoma that's been surgically removed. They must have good organ function, no other cancers in the past 5 years, and not be pregnant or nursing. Participants need to use effective contraception and can't have autoimmune disorders, heart failure, a history of stroke or ischemic heart disease, cognitive impairments, or be on immunosuppressive treatments.

Inclusion Criteria

My skin cancer is at Stage II with a thickness of 1.5-4.0 mm.

My skin cancer is confirmed as melanoma.

My lymph nodes do not show signs of cancer, either by clinical exam or biopsy.

My cancer is stage III with a tumor thicker than 4mm or has spread to one lymph node.

Exclusion Criteria

Clinical, radiological/laboratory, or pathological evidence of incompletely resected melanoma or any distant metastatic disease; Clinically palpable lymphadenopathy; Evidence of organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that would preclude study participation; Other significant medical or surgical condition, or any medication or treatment regimens, that would interfere with study participation; Pregnant or nursing; Other history of invasive melanoma; Autoimmune disorders or conditions of immunosuppression; History of active ischemic heart disease; Cerebrovascular disease; Congestive heart failure (New York Heart Association class III or IV heart disease); Prior or concurrent chemotherapy; Prior immunotherapy including tumor vaccines, interferon, interleukins, levamisole, or other biologic response modifiers for melanoma; Concurrent systemic corticosteroids including oral steroids (i.e., prednisone, dexamethasone), topical steroid creams or ointments, or any steroid-containing inhalers; Prior or concurrent radiotherapy; Other concurrent immunosuppressive medications

Treatment Details

The study is testing high-dose interferon alfa against just observation to see which is better at preventing cancer growth after surgery. Patients are randomly assigned to either get the drug treatment or undergo regular monitoring without additional therapy.

2Treatment groups

Experimental Treatment

Group I: ObservationExperimental Treatment1 Intervention

Patients undergo observation for 4 weeks.

Group II: Interferon Alfa-2bExperimental Treatment1 Intervention

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.