Vaccination of Patients With Stage IV Melanoma With Dendritic Cells - Full Text View

Sponsors and Collaborators:	Baylor Research Institute Baylor University Mary Crowley Medical Research Center ODC Therapy
Information provided by:	Baylor Research Institute
ClinicalTrials.gov Identifier:	NCT00125749

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 I Phase II

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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

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 ]
Feasibility of a novel approach to DC manufacture [ Time Frame: 3 years ]
Objective clinical responses [ Time Frame: 3 years ]

Secondary Outcome Measures:

Immunogenicity of frozen DC vaccinations [ Time Frame: 3 years ]

Estimated Enrollment:	30
Study Start Date:	July 2005
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

Baylor University

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

Click here for more information about this study. This link exits the ClinicalTrials.gov site

Study ID Numbers:	Baylor IRB #005-065-02
Study First Received:	August 1, 2005
Last Updated:	October 1, 2008
ClinicalTrials.gov Identifier:	NCT00125749
Health Authority:	United States: Food and Drug Administration

Keywords provided by Baylor Research Institute:

Dendritic
Vaccine
Melanoma
Stage IV metastatic melanoma

Study placed in the following topic categories:

Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neoplasm Metastasis

Neuroepithelioma
Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplastic Processes
Neoplasms
Pathologic Processes

Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 16, 2009