Clinical trial · Interventional
IL15 Dendritic Cell Vaccine for Patients With Resected Stage III (A, B or C) or Stage IV Melanoma
IL15-DC Vaccine in Patients With High Risk Melanoma - Exploratory Phase I/II Trial
NCT01189383CI-TRIAL-00025250completedPhase 1 / Phase 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)
The purpose of the study is to gather data on feasibility as well as immune and clinical efficacy of of a dendritic cell vaccine using IL15 in patients with resected stage III or stage IV melanoma
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IL15-DC Vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IL15-DC Vaccine
- description
- Approximately 9 x 10\^6 DCs will be injected (subcutaneously)total per vaccination visit. Patients will receive four vaccinations at weeks 0, 4, 8 and 12.At each scheduled vaccination the patient will receive a total of 3 injections, i.e., 3 mL injections at each of 3 anatomical locations.Injection sites are in upper and lower extremities. Subsequent DC injections will be rotated to different locations on the upper and lower extremities.
- interventionNames
- Biological: IL15-DC Vaccine
Primary outcomes (1)
- measure
- Immune response
- timeFrame
- 14 weeks
Secondary outcomes (3)
- measure
- Quality of elicited melanoma specific CD8+ T cells
- timeFrame
- 14 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * HLA A201 + phenotype * Biopsy-proven melanoma, Stages III (A, B and C) or stage IV.- no evidence of disease at study entry * Age: 21-75 years * ECOG performance status 0-1 * Adequate marrow function * Adequate hepatic function * Adequate renal function * Written informed consent Exclusion Criteria: * Subjects with measureable non-resectable melanoma * Subjects who have had chemotherapy less than 4 weeks before starting trial * Subjects who received IFN-a or GM-CSF less than 4 weeks before starting trial * Subjects who received IL2 less than 4 weeks before starting trial * Subjects with a baseline LDH greater than 1.1 times the ULN * Subjects who are HIV positive * Female subjects who are pregnant * Subjects who have received corticosteroids or other immunosuppressive agents less than 4 weeks before starting trial * Subjects who have asthma and/or are on treatment for asthma * Subjects with angina pectoris * Subjects with congestive heart failure * Subjects with history of autoimmune disease including lupus, rheumatoid arthritis or thyroiditis * Subjects with active infections including viral hepatitis * Subjects with a history of neoplastic disease othe than melanoma within the last 5 years * History of neoplastic disease within the last 5 years except for carcinoma in situ of the cervix, superficial bladder cancer or basal/squamous cell carcinoma of the skin. * Subjects who present with open wounds
References
Publications (0)
Data not yet available
No reference posted for this study.