IL15 Dendritic Cell Vaccine for Patients With Resected Stage III (A, B or C) or Stage IV Melanoma

Completed · Phase 1/Phase 2

Conditions studied: Malignant Melanoma Stage III, Malignant Melanoma Stage IV

In brief

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

Key facts

Study ID

NCT01189383

Run by

Baylor Research Institute

People needed

20

Starts

2011-01-01

Expected to finish

2016-12-01

Last updated by the study team

2016-12-22

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Baylor University Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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