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

Malignant Melanoma Stage IV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01189383
• Other study ID #: 009-273
• Secondary ID: R01CA140602
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 25, 2010
• Last updated: December 20, 2016
• Start date: January 2011
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Melanoma Stage III
• Malignant Melanoma Stage IV
• Melanoma

Intervention

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.

Locations

Country	Name	City	State
United States	Baylor University Medical Center	Dallas	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Baylor Research Institute	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune response		14 weeks	No
Secondary	Quality of elicited melanoma specific CD8+ T cells		14 weeks	No
Secondary	Breadth of melanoma specific immunity		24 weeks	No
Secondary	Longevity of melanoma specific CD8+ T cell immunity		24 weeks	No

External Links

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