Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Stage IV Melanoma
Phase I Trial of a Dendritic Cell Vaccine for Melanoma
NCT00003665CI-TRIAL-00009608completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma. Vaccines may make the body build an immune response to kill tumor cells.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dendritic cell-MART-1 peptide vaccine | Biological | — | UNRESOLVED |
| gp100 antigen | Biological | — | UNRESOLVED |
| therapeutic tumor infiltrating lymphocytes | Biological | Therapeutic Tumor Infiltrating Lymphocytes | ALIAS |
| tyrosinase peptide | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive 3 different doses of peptide pulsed DC vaccine IV, each divided into 3 different peptide pulsed pools administered over 30 minutes.
- interventionNames
- Biological: dendritic cell-MART-1 peptide vaccine
- Biological: gp100 antigen
- Biological: therapeutic tumor infiltrating lymphocytes
- Biological: tyrosinase peptide
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive 3 different doses of peptide pulsed DC vaccine subcutaneously/intradermally to sites with no evidence of disease. At the lowest dose, patients receive 3 different peptide pulsed pools, each administered at a separate site. At the higher doses, patients receive 3 injections further subdivided into 6 and administered at 6 distinct sites.
- interventionNames
- Biological: dendritic cell-MART-1 peptide vaccine
- Biological: gp100 antigen
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: -Histologically confirmed stage IV melanoma Must be MHC Class I HLA-A2.1 PATIENT CHARACTERISTICS: * Age: Over 18 * Performance status: ECOG 0-1 * Life expectancy: At least 2 months * Platelet count at least 100,000/mm3 * INR no greater than 1.5 mg/dL * No coagulopathies including thrombocytopenia * Partial thromboplastin time no greater than 50 seconds * No major cardiac illness * No major respiratory illness * No active systemic infection or other illness * No peripheral vascular disease * Not pregnant or nursing * Effective contraception required of all fertile patients during and for one month after completion of treatment PRIOR CONCURRENT THERAPY: * At least 30 days since prior immunotherapy * No concurrent immunotherapy * At least 30 days since prior chemotherapy * No concurrent chemotherapy * At least 30 days since prior radiotherapy * No concurrent radiotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.