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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01189383
Recruitment Status : Completed
First Posted : August 26, 2010
Last Update Posted : December 22, 2016
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Baylor Research Institute

Study Description
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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

Condition or disease Intervention/treatment Phase
Malignant Melanoma Stage III Malignant Melanoma Stage IV Biological: IL15-DC Vaccine Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: IL15-DC Vaccine in Patients With High Risk Melanoma - Exploratory Phase I/II Trial
Study Start Date : January 2011
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma Vaccines

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Immune response [ Time Frame: 14 weeks ]

Secondary Outcome Measures :
  1. Quality of elicited melanoma specific CD8+ T cells [ Time Frame: 14 weeks ]
  2. Breadth of melanoma specific immunity [ Time Frame: 24 weeks ]
  3. Longevity of melanoma specific CD8+ T cell immunity [ Time Frame: 24 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189383


Locations
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United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Baylor Research Institute
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Joseph Fay, MD Baylor Health Care System
More Information
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Additional Information:

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Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT01189383    
Other Study ID Numbers: 009-273
R01CA140602 ( U.S. NIH Grant/Contract )
First Posted: August 26, 2010    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016
Keywords provided by Baylor Research Institute:
Melanoma
Vaccine
Dendritic Cell
 Immune response
Safety
Efficacy
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas