High-Dose Interferon Alfa for Melanoma

Recruiting in Palo Alto (17 mi)

+532 other locations

Overseen by Alberto 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.

Research Team

William E. Carson, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Alberto S. Pappo, MD

Principal Investigator

Texas Children's Cancer Center

Michael Smylie, MD, MB, ChB

Principal Investigator

Cross Cancer Institute at University of Alberta

Sanjiv S. Agarwala, MD

Principal Investigator

St. Luke's Cancer Network at St. Luke's Hospital

John M. Kirkwood, MD

Principal Investigator

UPMC Cancer Center at UPMC Presbyterian

Lawrence E. Flaherty, MD

Principal Investigator

Barbara Ann Karmanos Cancer Institute

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.

Patients must meet at least 1 of the following criteria: T2b N0 - primary melanoma 1.01-2.0 mm with ulceration, node negative; T3a-b N0 - primary melanoma 2.01-4.0 mm with and without ulceration, node negative; T4a-b N0 - primary melanoma > 4.0 mm with or without ulceration, node negative; T1a N1a-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; Age 18 and over (For ECOG patients only, patients must be >=10 years); Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1; Adequate hematopoietic, hepatic, and renal function based on specified tests; No other concurrent or prior malignancies within the past 5 years except specified cases; Negative pregnancy test; Fertile patients must use effective contraception during and for 6 months after study

My skin cancer is confirmed as melanoma.

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

Interventions

• Interferon alfa-2b (Interferon)

Trial Overview 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.

Participant Groups

Group I: Observation Experimental Treatment 1 Intervention

Patients undergo observation for 4 weeks.

Group II: Interferon Alfa-2b Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

ECOG-ACRIN Cancer Research Group

Lead Sponsor

Trials

122

Recruited

160,000+

Dr. Peter J. O'Dwyer

ECOG-ACRIN Cancer Research Group

Chief Executive Officer since 2012

MD from University of Pennsylvania

Dr. Mitchell D. Schnall

ECOG-ACRIN Cancer Research Group

Chief Medical Officer since 2012

MD, PhD from University of Pennsylvania

Southwest Oncology Group

Collaborator

Trials

389

Recruited

260,000+

Dr. Lyudmila Bazhenova

Southwest Oncology Group

Chief Medical Officer since 2021

MD from University of California, San Diego

Dr. Richard Schilsky

Southwest Oncology Group

Chief Executive Officer since 2013

MD from University of California, San Diego

SWOG Cancer Research Network

Collaborator

Trials

403

Recruited

267,000+

Dr. Charles D. Blanke

SWOG Cancer Research Network

Chief Executive Officer since 2012

MD from Oregon Health & Science University

Dr. Dawn Hershman

SWOG Cancer Research Network

Chief Medical Officer since 2020

MD from Columbia University

NCIC Clinical Trials Group

Collaborator

Trials

190

Recruited

145,000+

Dr. Lesley Seymour

NCIC Clinical Trials Group

Chief Medical Officer since 2014

MD from University of Toronto

Dr. Janet Dancey

NCIC Clinical Trials Group

Chief Executive Officer since 2014

MD from Queen's University

Cancer and Leukemia Group B

Collaborator

Trials

81

Recruited

118,000+

Dr. Richard L. Schilsky

Cancer and Leukemia Group B

Chief Executive Officer since 2012

MD from University of Chicago

Dr. Walter Stadler

Cancer and Leukemia Group B

Chief Medical Officer since 2012

MD from Harvard Medical School

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Children's Oncology Group

Collaborator

Trials

467

Recruited

241,000+

Dr. Doug Hawkins

Children's Oncology Group

Chief Executive Officer since 2020

MD from University of Washington School of Medicine

Dr. Leo Mascarenhas

Children's Oncology Group

Chief Medical Officer since 2024

MD, MS from Cedars-Sinai Guerin Children’s