Clinical trial · Interventional
Comparison of Dendritic Cells Versus Montanide as Adjuvants in a Melanoma Vaccine
A Randomized, Controlled Trial of Melanoma Treatment: Comparison of Dendritic Cells Versus Montanide as Adjuvants to Stimulate Anti-tumor Immunity
NCT00124124CI-TRIAL-00016868completedPhase 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)
In this study, a melanoma vaccine (5 melanoma peptides) is given with either Montanide or dendritic cells as adjuvants. This randomized trial will establish the safety of both vaccines and compare the 2 vaccine adjuvants in their efficacy to induce immune responses.
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 | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KLH; Peptides; Dendritic Cells | Drug | — | UNRESOLVED |
| KLH, peptides plus Montanide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- KLH and peptide pulsed DCs
- interventionNames
- Drug: KLH; Peptides; Dendritic Cells
- type
- EXPERIMENTAL
- label
- 2
- description
- KLH, peptides plus Montanide
- interventionNames
- Drug: KLH, peptides plus Montanide
Primary outcomes (1)
- measure
- Immunology
- timeFrame
- Examine whether DCs pulsed with candidate melanoma-specific peptides and KLH can boost CTL responses to melanoma antigens
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Resected stage IIB, IIC, or stage III melanoma. * Fully recovered from surgery * Human leukocyte antigen (HLA) A\*0201 positive. * Age \>18 years. * Karnofsky performance status: \>80% and normal labs. Exclusion Criteria: * Prior chemotherapy. * Known chronic infection with HIV, hepatitis B or C. * Patients with known autoimmune disease \[e.g. systemic lupus erythematosus (SLE), rheumatoid arthritis (RA)\]. Patients with vitiligo are not excluded. * Pregnant women. * Patients with known allergy to gentamicin, tobramycin, streptomycin and amikacin (risk of cross-reaction between aminoglycosides). * Patients who have known retinal or choroidal eye disease. * Patients previously treated with one of the peptides used in this trial, melanoma protein vaccine, melanoma whole cell vaccines, or with Montanide are not eligible. * Allergy to shellfish.
References
Publications (0)
Data not yet available
No reference posted for this study.