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Vaccination of Patients With Stage IV Melanoma With Dendritic Cells

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: NCT00125749
Recruitment Status : Completed
First Posted : August 2, 2005
Last Update Posted : June 12, 2017
Sponsor:
Collaborators:
Mary Crowley Medical Research Center
ODC Therapy
Information provided by (Responsible Party):
Baylor Research Institute

Study Description
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Brief Summary:
The purpose of this study is to test a novel dendritic cell (DC) vaccine in patients with Stage IV melanoma.

Condition or disease Intervention/treatment Phase
Melanoma Neoplasm Metastasis Biological: Dendritic cell vaccination Phase 1 Phase 2

Detailed Description:

A novel dendritic cell vaccine has been developed at the Baylor Institute for Immunology Research (BIIR). Pre-clinical studies have found that this dendritic cell vaccine is more efficient in inducing a tumor specific immunity than other dendritic cell vaccines. Further studies in the BIIR have been done with dendritic cells that were loaded with killed melanoma cells from a melanoma cell line treated with heat before loading. Both studies have shown that DCs manufactured in this novel way were more efficient in priming the melanoma specific CD8+ cells. Thus, the strategy for this clinical trial will be to test recent laboratory findings in the clinical setting. An additional objective of the study will be to determine the effectiveness of a frozen vaccine product which differs from previous vaccines that were manufactured "fresh".

This clinical trial will evaluate the novel dendritic cell vaccine in patients with Stage IV melanoma. The trial will accrue a total of 30 subjects. The primary goal of this trial will be to test the safety/tolerability/feasibility of the vaccine preparation and the rate of objective clinical response. A 15% objective response rate will be accepted in patients who have failed previous therapy with IL-2 and/or dacarbazine (DTIC) and/or temozolomide which are standard treatments for patients with malignant melanoma.

Each subject will be given 7 initial injections in a fixed dose amount. The first 4 doses will be given at 2-week intervals (Weeks 0, 2, 4 and 6); the last 3 doses will be given at 4-week intervals (Weeks 10, 14, and 18). Those patients who exhibit stable disease, partial response or complete response after 7 injections will be given 4 more vaccinations. Each of these additional 4 vaccinations will be given 3 months apart (Weeks 36, 48, 72 and 96). Scans and re-staging tests will be performed at scheduled intervals throughout the study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vaccination of Patients With Stage IV Melanoma With Dendritic Cells Generated Ex Vivo From Monocytes and Loaded With Heat Treated Killed Allogeneic Melanoma Cells
Study Start Date : July 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

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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Intervention Details:
  • Biological: Dendritic cell vaccination
    Autologous Dendritic Cells Derived from PBMC, Cultured with Cytokines, Pulsed Ex Vivo with Irradiated Allogeneic (Colo 829) Melanoma Cells

Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability of the novel DC vaccination product in human subjects [ Time Frame: 3 years ]
  2. Feasibility of a novel approach to DC manufacture [ Time Frame: 3 years ]
  3. Objective clinical responses [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Immunogenicity of frozen DC vaccinations [ Time Frame: 3 years ]

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:

  • Stage M1a, M1b, M1c biopsy proven metastatic melanoma
  • Failure of at least one prior chemotherapy regimen of DTIC and/or temozolomide with/without interleukin-2 (IL-2).
  • Karnofsky performance status greater than/equal to 80%.
  • Measurable metastatic lesions by physical exam or scans.
  • Acceptable CBC and blood chemistry results
  • Adequate renal function.
  • Written informed consent.

Exclusion Criteria:

  • Patients who have received more than 8 cycles of chemotherapy for metastatic melanoma.
  • Patients who have received chemotherapy less than 4 weeks before beginning the trial.
  • Patients who have received interferon (IFN) alpha-2b or granulocyte-monocyte colony-stimulating factor (GM-CSF) less than 4 weeks before beginning the trial.
  • Patients who have received high-dose IL-2 less than 4 weeks before beginning the trial.
  • Patients with a history of central nervous system (CNS) metastatic melanoma.
  • More than 5 hepatic lesions or any hepatic lesion larger than 5 cm.
  • Baseline serum LDH greater than 4 times the upper limit of normal.
  • Patients who are HIV positive.
  • Patients who are pregnant.
  • Patients who have received corticosteroids or other agents less than 4 weeks before beginning the trial.
  • Patients with asthma, angina pectoris or congestive heart failure.
  • Patients with autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.
  • Patients with active infections including viral hepatitis.
  • Patients with a history of any other neoplastic disease less than 5 years ago (carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin, however, can be admitted to the study).
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): NCT00125749


Locations
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United States, Texas
Mary Crowley Medical Research Center: Baylor University Medical Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Baylor Research Institute
Mary Crowley Medical Research Center
ODC Therapy
Investigators
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Study Director: Anna Karolina Palucka, MD, PhD Baylor Institute for Immunology Research: Baylor University Medical Center
More Information
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Additional Information:

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Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT00125749    
Other Study ID Numbers: 005-065-02
First Posted: August 2, 2005    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017
Keywords provided by Baylor Research Institute:
Dendritic
Vaccine
Melanoma
Stage IV metastatic melanoma
Additional relevant MeSH terms:
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Melanoma
Neoplasm Metastasis
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes