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

NCT00447356 | Withdrawn Phase 3 DMC

• 1 other identifier: E1697
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melanoma (Skin)

Interventions

recombinant interferon alfa DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Hackensack Meridian Health: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

The Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Related Publications (1)

• Slawek-Szmyt S, Araszkiewicz A, Jankiewicz S, Grygier M, Mularek-Kubzdela T, Lesiak M. Outcomes With Hybrid Catheter-Directed Therapy Compared With Aspiration Thrombectomy for Patients With Intermediate-High Risk Pulmonary Embolism. Cardiovasc Drugs Ther. 2025 Oct;39(5):1201-1213. doi: 10.1007/s10557-024-07562-4. Epub 2024 Apr 2.

  PMID: 38564122 DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

Interferon-alpha

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• David S. Siegel, MD

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2007
• First Posted: March 14, 2007
• Study Start: January 1, 2000
• Last Updated: May 13, 2013

Record last verified: 2013-05

Locations

US (1)