At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed stage III or IV melanoma with at least one metastatic lymph node and/or at least one in-transit metastasis
- ✓Tumor expression of Melan-A by RT-PCR (group I) or Melan-A plus at least one of MAGE-A10/NY-ESO-1/LAGE-1 by RT-PCR (groups II-III, HLA-A2+ in IV-V), or NY-ESO-1 only for HLA-A2 negative in groups IV-V; immunohistochemistry acceptable if frozen tissue unavailable
- ✓HLA-A2 positive for groups 1-3; HLA-A2+ or HLA-A2- acceptable for groups 4-5
- ✓Expected survival of at least 5 months
- ✕Clinically significant heart disease (NYHA Class III or IV)
- ✕Other serious illnesses including serious infections requiring antibiotics, uncontrolled peptic ulcer, or CNS disorders with major dysfunction
- ✕History of immunodeficiency disease or autoimmune disease
- ✕Known HIV positivity or seropositivity for hepatitis B surface antigen
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Vaccination of Patients With Stage III or IV Malignant Melanoma With Melanoma Antigen Peptides [Melan-A/Mart-1 Analog (ELA), NY-ESO-1b(A) Analog and MAGE-A10] and Montanide Adjuvant
In Brief
A Phase 1 clinical trial evaluating Melan-A ELA + Montanide, Melan-A ELA + NY-ESO-1b + MAGE-A10 + Montanide, and 3 other interventions for Melanoma. Completed, enrolled 39 participants across 2 sites.
Detailed Summary
The purpose of this study is to determine whether vaccination with melanoma antigen peptides \[Melan-A/Mart-1 (both EAA and ELA), NY-ESO-1b analog, Long NY-ESO-1 LP and MAGE-A10\] and Montanide, CpG adjuvants and low dose rIL-2 can induce an immune response in melanoma patients and to assess the safety of this vaccination.
Study Details
Timeline
Interventions
A maximum of 3 vaccination cycles (cycles 1-3) has been given, each cycle consisting of 4 vaccines in 4 week intervals. The intervals between cycles were 8 weeks. After 3 cycles, patients without major tumor progression requiring other treatment who showed an immunological response received "booster vaccinations" every 3 months.
A maximum of 3 vaccination cycles (cycles 1-3) has been given, each cycle consisting of 4 vaccines in 4 week intervals. The intervals between cycles were 8 weeks. After 3 cycles, patients without major tumor progression requiring other treatment who showed an immunological response received "booster vaccinations" every 3 months.
A maximum of 3 vaccination cycles (cycles 1-3) has been given, each cycle consisting of 4 vaccines in 4 week intervals. The intervals between cycles were 8 weeks. After 3 cycles, patients without major tumor progression requiring other treatment who showed an immunological response received "booster vaccinations" every 3 months.
A maximum of 3 vaccination cycles (cycles 1-3) has been given, each cycle consisting of 4 vaccines in 4 week intervals. The intervals between cycles were 8 weeks. After 3 cycles, patients without major tumor progression requiring other treatment who showed an immunological response received "booster vaccinations" every 3 months.
A maximum of 3 vaccination cycles (cycles 1-3) has been given, each cycle consisting of 4 vaccines in 4 week intervals. The intervals between cycles were 8 weeks. After 3 cycles, patients without major tumor progression requiring other treatment who showed an immunological response received "booster vaccinations" every 3 months.