Randomized, open phase II study of immunization with the recombinant MAGE-3 protein combined with adjuvant AS02B or AS15 in patients with unresectable and progressive metastatic cutaneous melanoma

European Organisation for Research and Treatment of Cancer0 sites0 target enrollmentApril 26, 2006

Conditionsnresectable and progressive metastatic cutaneous melanoma MedDRA version: 7.0Level: LLTClassification code 10027155

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: nresectable and progressive metastatic cutaneous melanoma
Sponsor: European Organisation for Research and Treatment of Cancer
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 26, 2006

End Date

May 26, 2008

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

European Organisation for Research and Treatment of Cancer

Eligibility Criteria

Inclusion Criteria

•1\.The patient has histologically proven measurable metastatic cutaneous melanoma.
•Patients with any skin, soft\-tissue or lymph\-node metastasis can be included in the study, provided the disease is not amenable to curative treatment with surgery. In terms of AJCC 2001 classification, this means that patients with unresectable stage III melanoma or with stage IV M1a melanoma are candidates for inclusion, whereas patients with stage IV M1b or IV M1c disease cannot be included in the study.
•The patient must present a documented progressive disease within 12 weeks before the first vaccine administration.
•2\.The tumor sample expresses the MAGE\-3 gene, as determined by RT\-PCR analysis (more than 1% of the positive MAGE\-3 control included in the assay).
•3\.The patient is at least 18 years old.
•4\.If the patient is a woman of childbearing potential, the urine pregnancy test should be done \= 1 week before randomization and should be negative.
•5\.If the patient is a woman of childbearing potential, she must consent to use oral contraception or an IUD during the treatment and until three months have elapsed after the last injection.
•6\.No previous systemic chemotherapy, except isolated limb perfusion which should be performed \> 4 weeks from randomization.
•7\.No previous vaccine containing a MAGE 3 antigen, and no previous vaccine for the metastatic stage.
•Prior adjuvant vaccine containing other tumor antigen than MAGE\-3 is allowed if the last vaccine has been injected eight weeks before the randomization.