Vaccination of Patients With Stage IV Melanoma With Dendritic Cells

This study has been completed.
Sponsor:
Collaborators:
Mary Crowley Medical Research Center
ODC Therapy
Information provided by (Responsible Party):
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT00125749
First received: August 1, 2005
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Melanoma
Neoplasm Metastasis
Biological: Dendritic cell vaccination
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Baylor Research Institute:

Primary Outcome Measures:
  • Safety and tolerability of the novel DC vaccination product in human subjects [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Feasibility of a novel approach to DC manufacture [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Objective clinical responses [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity of frozen DC vaccinations [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: July 2005
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125749

Locations
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
Study Director: Anna Karolina Palucka, MD, PhD Baylor Institute for Immunology Research: Baylor University Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT00125749     History of Changes
Other Study ID Numbers: Baylor IRB #005-065-02
Study First Received: August 1, 2005
Last Updated: September 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Baylor Research Institute:
Dendritic
Vaccine
Melanoma
Stage IV metastatic melanoma

Additional relevant MeSH terms:
Neoplasms
Melanoma
Neoplasm Metastasis
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014