PegIntron Versus IntronA in CMAJCC Stage II (EADO 2001/CMII Trial)

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Melanoma with a tumor thickness >= 1.5mm without clinically detectable nodes represents an increasing population with relapse rate of more than 50%. Adjuvant therapy with low doses of IFN alpha can provide a benefit in this group. However, the impact of low dose IFN alpha is not sustained after the treatment period. A longer treatment may prolong the benefit and thus have a more clear-cut impact on disease-free and overall survival. The tolerance and the impact on quality of life are limiting factors in a group of patients whose individual course is not necessarily poor. PegIntron may be better tolerated than instant release interferon, and thus make this treatment more acceptable in terms of toxicity and quality of life. Thus treatment schedule with PegIntron is not expected to increase the cost of standard care significantly.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Collaborator: Schering-Plough
• Treatments: Interferon-alpha; Peginterferon alfa-2b

Criteria

Inclusion Criteria:

• Histologically proven cutaneous melanoma

• Tumour thickness >= 1.5 mm (Breslow staging)

• Absence of clinically detectable regional node metastasis, no evidence of distant metastasis

• Informed consent form signed

Exclusion Criteria:

• Any prior chemo-, immuno-, hormonal or radiation therapy

• Macroscopic disease