Malignant Melanoma Stage III, Malignant Melanoma Stage IV
Conditions
Keywords
Melanoma, Vaccine, Dendritic Cell, Immune response, Safety, Efficacy
Brief summary
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
Detailed description
IL15 is a T cell growth factor that pre-clinical data overwhelmingly suggests could have a very important role in cancer immunotherapy. A desirable property for a dendritic cell vaccine directed against cancer is the ability to efficiently prime naïve, tumor associated antigen specific T cells into potent CTLs. Results of studies in healthy volunteers have shown that IL15 DCs are particularly efficient at priming functional melanoma specific CD8+ T cells. The use of IL15 in the manufacture of the DC vaccine could result in an improved immunotherapy product.
Interventions
BIOLOGICALIL15-DC Vaccine
Autologous dendritic cells manufactured with GM-CSF, IL15 and loaded with melanoma/HIV peptides and KLH; then activated with LPS and CD40 Ligand. 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.
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Baylor Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immune response | 14 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Quality of elicited melanoma specific CD8+ T cells | 14 weeks |
| Breadth of melanoma specific immunity | 24 weeks |
| Longevity of melanoma specific CD8+ T cell immunity | 24 weeks |
Countries
United States
Outcome results
None listed