CompletedPhase 1

Immunotherapy of HLA-A2 Positive Stage III/IV Melanoma Patients

Switzerland29 participantsStarted 2003-04

Plain-language summary

The purpose of this study is to determine whether vaccination with tumor antigenic peptides and both CpG and Montanide adjuvants can induce an immune response in melanoma patients and to assess the safety of this vaccination.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histologically confirmed stage III or stage IV melanoma * Tumor expression of Melan-A +/- Tyrosinase * Human leukocyte antigen-A2 (HLA-A2) positive Exclusion Criteria: * Clinically significant heart disease * Serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders or uncontrolled peptic ulcer, or seizure or central nervous system disorders * History of immunodeficiency disease or autoimmune disease * Coagulation or bleeding disorders

What they're measuring

Melan-A and Tyrosinase specific CD8+ T-cell reactivity will be measured by Tetramers and Elispot assays

Timeframe: Change from baseline in CD8 T-cells reactivity at day 375

Safety of vaccination will be assessed according to National Cancer Institute Common Toxicity Criteria (NCI CTC) scale

Timeframe: Change from baseline to day 375

Trial details

NCT IDNCT00112229

SponsorCentre Hospitalier Universitaire Vaudois

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-08

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