IL15-DC Vaccine in Patients With High Risk Melanoma - Exploratory Phase I/II Trial
21 Years
75 Years
Both
Malignant Melanoma Stage III, Malignant Melanoma Stage IV
Trial Information
IL15-DC Vaccine in Patients With High Risk Melanoma - Exploratory Phase I/II Trial
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Immune response
Outcome Time Frame:
14 weeks
Safety Issue:
No
Principal Investigator
Joseph Fay, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Baylor Health Care System
Authority:
United States: Food and Drug Administration
Study ID:
009-273
NCT ID:
NCT01189383
Start Date:
January 2011
Completion Date:
September 2014
Related Keywords:
- Malignant Melanoma Stage III
- Malignant Melanoma Stage IV
- Melanoma
- Vaccine
- Dendritic Cell
- Immune response
- Safety
- Efficacy
- Melanoma
Name | Location |
|---|---|
| Baylor University Medical Center | Dallas, Texas 75246 |
