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

IL15-DC Vaccine in Patients With High Risk Melanoma - Exploratory Phase I/II Trial

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

Study Overview

• Status: Completed
• Conditions: Malignant Melanoma Stage III; Malignant Melanoma Stage IV
• Intervention / Treatment: Biological: IL15-DC Vaccine

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Immune response	14 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of elicited melanoma specific CD8+ T cells	14 weeks
Breadth of melanoma specific immunity	24 weeks
Longevity of melanoma specific CD8+ T cell immunity	24 weeks

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Joseph Fay, MD, Baylor Health Care System

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: August 25, 2010
• First Submitted That Met QC Criteria: August 25, 2010
• First Posted (Estimate): August 26, 2010

Study Record Updates

• Last Update Posted (Estimate): December 22, 2016
• Last Update Submitted That Met QC Criteria: December 20, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Vaccine; Melanoma; Immune response; Dendritic Cell
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: 009-273; R01CA140602 (U.S. NIH Grant/Contract)