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

NCT ID: NCT01189383

Last Updated: 2016-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2016-12-31

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.

Conditions

Malignant Melanoma Stage III; Malignant Melanoma Stage IV

Keywords

Melanoma; Vaccine; Dendritic Cell; Immune response; Safety; Efficacy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IL15-DC Vaccine

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.

Group Type: EXPERIMENTAL

IL15-DC Vaccine

Intervention Type: BIOLOGICAL

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.

Interventions

IL15-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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Fay, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor Health Care System

Locations

Baylor University Medical Center

Dallas, Texas, United States

Countries

United States

Related Links

http://www.baylorhealth.com/AdvancingMedicine/GetInvolved/Pages/BRI_Display.aspx?IRBNumber=IRB-009-273

Click here for more information on this study: IL15-DC Vaccine in Patients With High Risk Melanoma - Exploratory Phase I/II Trial

Other Identifiers

R01CA140602

Identifier Type: NIH

Identifier Source: secondary_id

View Link

009-273

Identifier Type: -

Identifier Source: org_study_id