Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Metastatic Melanoma
A Phase II Trial of an Intradermally Administered MART-1gp100/Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Matured With a Cytokine Cocktail for Patients With Metastatic Melanoma
NCT00334776CI-TRIAL-00014619completedPhase 2ClinicalTrials.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)
RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill melanoma cells. PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with metastatic melanoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intraocular Melanoma | Uveal Melanoma | ALIAS | 0.90 |
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gp100:209-217(210M) peptide vaccine | Biological | — | UNRESOLVED |
| MART-1 antigen | Biological | — | UNRESOLVED |
| therapeutic autologous dendritic cells | Biological | — | UNRESOLVED |
| tyrosinase peptide | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Overall survival
- measure
- Progression-free survival
- measure
- Time to progression
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of melanoma
* Metastatic disease
* The following melanoma subtypes are eligible:
* Unresectable, stage III-IV uveal melanoma
* Metastatic mucosal melanoma
* Measurable disease after attempted curative surgical therapy
* Tumor tissue must be available for immunohistochemical staining
* Positive for ≥ 1 of the following peptides:
* MART-1: 26-35 (27L)
* gp100: 209-217 (210M)
* Tyrosinase: 368-376 (370D)
* HLA-A \*0201 positive by DNA polymerase chain reaction assay
PATIENT CHARACTERISTICS:
* ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
* Creatinine ≤ 2.0 mg/dL
* Bilirubin ≤ 2.0 mg/dL
* WBC ≥ 3,000/mm\^3
* Platelet count ≥ 75,000/mm\^3
* Hemoglobin ≥ 9.0 g/dL
* No major systemic infections
* No coagulation disorders
* No major medical illness of the cardiovascular or respiratory system
* No myocardial infarction within the past 6 months
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known HIV positivity
* No know positivity for hepatitis B surface antigen or hepatitis C antibody
* No prior uveitis or autoimmune inflammatory eye disease
* No other prior malignancy except cervical carcinoma in situ or basal cell skin cancer unless patient was curatively treated \> 5 years ago and has no detectable disease
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No more than 1 prior cytotoxic chemotherapy agent or regimen
* Prior biologic or antiangiogenic therapies allowed
* More than 1 month since prior and no concurrent radiotherapy, chemotherapy, adjuvant therapy, or any other therapy for melanoma
* No prior MART-1: 26-35 (27L), gp100: 209-217 (210M), or tyrosinase: 368-376 (370D) peptides
* No concurrent steroid therapyReferences
Publications (0)
Data not yet available
No reference posted for this study.