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

Baylor Scott and White Health (BSWH)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Malignant Melanoma Stage III; Malignant Melanoma Stage IV

Treatments: Biological: IL15-DC Vaccine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01189383

009-273

R01CA140602 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

IL15-DC Vaccine

Experimental group

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.

Treatment:

Biological: IL15-DC Vaccine