Status:
COMPLETED
IL15 Dendritic Cell Vaccine for Patients With Resected Stage III (A, B or C) or Stage IV Melanoma
Lead Sponsor:
Baylor Research Institute
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Malignant Melanoma Stage III
Malignant Melanoma Stage IV
Eligibility:
All Genders
21-75 years
Phase:
PHASE1
PHASE2
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 again...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01189383
Start Date
January 1 2011
End Date
December 1 2016
Last Update
December 22 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Baylor University Medical Center
Dallas, Texas, United States, 75246