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

Phase III Randomized Study of Four Weeks High Dose IFN-2b in StageT3-T4 or N1 (Microscopic) Melanoma

NCT00447356•Hackensack Meridian Health

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.

Detailed Description

Interferon alfa may interfere with 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
+28 more criteria

Exclusion Criteria

•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
+13 more criteria

Locations (1)

The Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Key Dates

Start Date

January 1, 2000

Last Updated

May 13, 2013

Conditions

Melanoma (Skin)

Interventions

recombinant interferon alfa

DRUG

SCIB1 and iSCIB1+ in Melanoma Patients Receiving Nivolumab With Ipilimumab or SCIB1 With Pembrolizumab (The SCOPE Study)

NCT04079166

Malignant MelanomaMelanoma (Skin)+2 more

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COMPLETED

A Prospective Observational Study on Targeted Therapy for Unresectable or Metastatic BRAFV600E Mutant Melanoma Patients

NCT04911998

Melanoma (Skin)Metastatic Melanoma+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 13, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

SCIB1 and iSCIB1+ in Melanoma Patients Receiving Nivolumab With Ipilimumab or SCIB1 With Pembrolizumab (The SCOPE Study)

A Prospective Observational Study on Targeted Therapy for Unresectable or Metastatic BRAFV600E Mutant Melanoma Patients

Pembrolizumab and EDP1503 in Advanced Melanoma

FAPi Radioligand OpeN-Label, Phase 1 Study to Evaluate Safety, Tolerability and DosImetry of [Lu-177]-PNT6555; A Dose Escalation Study for TReatment of Patients With Select Solid Tumors (FRONTIER)

Head and Neck Melanoma; Access to Staging and Surgical Treatment

Nous-PEV: a Novel Immunotherapy for Lung Cancer and Melanoma