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

Primary Purpose

Malignant Melanoma Stage III, Malignant Melanoma Stage IV

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IL15-DC Vaccine
Sponsored by
Baylor Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Melanoma Stage III focused on measuring Melanoma, Vaccine, Dendritic Cell, Immune response, Safety, Efficacy

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Baylor University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IL15-DC Vaccine

Arm 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.

Outcomes

Primary Outcome Measures

Immune response

Secondary Outcome Measures

Quality of elicited melanoma specific CD8+ T cells
Breadth of melanoma specific immunity
Longevity of melanoma specific CD8+ T cell immunity

Full Information

First Posted
August 25, 2010
Last Updated
December 20, 2016
Sponsor
Baylor Research Institute
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01189383
Brief Title
IL15 Dendritic Cell Vaccine for Patients With Resected Stage III (A, B or C) or Stage IV Melanoma
Official Title
IL15-DC Vaccine in Patients With High Risk Melanoma - Exploratory Phase I/II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma Stage III, Malignant Melanoma Stage IV
Keywords
Melanoma, Vaccine, Dendritic Cell, Immune response, Safety, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IL15-DC Vaccine
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
IL15-DC Vaccine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Immune response
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Quality of elicited melanoma specific CD8+ T cells
Time Frame
14 weeks
Title
Breadth of melanoma specific immunity
Time Frame
24 weeks
Title
Longevity of melanoma specific CD8+ T cell immunity
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Fay, MD
Organizational Affiliation
Baylor Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.baylorhealth.com/AdvancingMedicine/GetInvolved/Pages/BRI_Display.aspx?IRBNumber=IRB-009-273
Description
Click here for more information on this study: IL15-DC Vaccine in Patients With High Risk Melanoma - Exploratory Phase I/II Trial

Learn more about this trial

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

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