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Clinical Trials/NCT00086866
NCT00086866UnknownPhase 2

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 Cancer - EORTC42 sites in 7 countries165 target enrollmentStarted: May 2004Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Enrollment
165
Locations
42
Primary Endpoint
Vaccine-related toxicity as assessed by CTCAE v3
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: This randomized phase II trial is studying two different regimens of vaccine therapy and comparing them to see how well they work in treating patients with stage III or stage IV melanoma that cannot be removed with surgery.

Detailed Description

OBJECTIVES:

Primary

  • Compare the objective response rate (complete and partial response) in patients with unresectable stage III or stage IV M1a cutaneous melanoma immunized with vaccine comprising D1/3-MAGE-3-His fusion protein and SB-AS02B adjuvant vs SB-AS15 adjuvant.
  • Compare the activity of SB-AS02B adjuvant vs SB-AS15 adjuvant, in terms of maximizing the antigenicity of MAGE-3, in patients treated with these regimens.
  • Compare the rate of grade 3/4 vaccine-related toxicity in patients treated with these regimens.

Secondary

  • Compare progression-free survival in patients treated with these regimens.

Study Design

Study Type
Interventional
Allocation
Randomized
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Vaccine-related toxicity as assessed by CTCAE v3

Response rate (complete response and partial response) as assessed by RECIST criteria

Secondary Outcomes

  • Rate of stabilization as assessed by RECIST criteria
  • Rate of immune response
  • Rate of mixed response as assessed by RECIST criteria
  • Progression-free survival

Investigators

Sponsor Class
Network
Responsible Party
Sponsor

Study Sites (42)

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