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The Use of Dendritic Cell/Tumor Hybridomas as a Novel Tumor Vaccine in Patients With Advance 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: NCT00626860
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : March 28, 2017
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
David Avigan, Beth Israel Deaconess Medical Center

Study Description
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Brief Summary:
This study aims to determine if the vacccine can be used safely in patients with advanced melanoma (cancer of the pigment cells) and whether the cells in this vaccine are capabale of producing immune responses against your own cancer.

Condition or disease Intervention/treatment Phase
Metastatic Melanoma Biological: DC/tumor fusion vaccine Phase 1 Phase 2

Detailed Description:
To assess the toxicity associated with vaccination of melanoma patients with dendritic cell (DC)/tumor fusions. To determine if cellular and humoral immunity can be induced by serial vaccination with DC/tumor fusions cells. To determine if vaccination DC/tumor fusions results in a tumor response.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Dendritic Cell/Tumor Hybridomas as a Novel Tumor Vaccine in Patients With Advance Melanoma
Study Start Date : July 2000
Actual Primary Completion Date : January 2002
Actual Study Completion Date : September 10, 2008

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: DC/tumor fusion vaccine
    SC vaccinations administered to each patient at 3-week intervals for 2-3 doses

Outcome Measures
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Primary Outcome Measures :
  1. To assess the toxicity, cellular and humoral immunity and tumor response in patient with melanoma receiving the DC/tumor fusion vaccine [ Time Frame: screening/baseline, treatment period and follow-up ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with confirmed diagnoses of disseminated melanoma, with measurable and clearly progressive metastatic involevment
  • Patients must be at least 18 years old
  • Patients must have ECOG performance status 0-1 with greater than 9 week life expectancy
  • Those patients with the following accessible tumor will be eligible: soft tissue, bone marrow or visceral lesions; Skin or superficial soft tissue, or lymph nodes amenable to resection under local anesthesia; Patients who require surgical procedures that are not considered significantly invasive but may require general anesthesia, such as thorascopic biopsy, laparascopic biopsy or mediastinal node biopsy may potentially be eligible; Malignant ascites or pleural effusion; Patients requiring major surgical intervention will be considered ineligible. Patients scheduled to undergo tumor resection for independent diagnostic or therapeutic indications may have tumor collected for the purposes of this study.
  • Labs: WBC >_ 2.0 x 10x3/uL, Bilirubin <_2.0 mg/dL, Creatine <_ 2.0mg/dL
  • Women of childbearing age must have a negative pregnancy test and adequate contraception method(s) must be documented
  • All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria:

  • Patients must not have received other immunotherapy treatment in the past four weeks prior to study entry
  • Patients must not have received chemotherapy for three weeks prior to the first vaccination
  • Patients must be without evidence of active CNS disease
  • Patients must not have clinically significant autoimmune disease
  • Patients must be HIV negative
  • Patients must not have serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure
  • Patients requiring corticosteroids for either melanoma related or co-morbid illness
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): NCT00626860


Locations
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United States, Massachusetts
BIDMC
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Genzyme, a Sanofi Company
Investigators
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Principal Investigator: David Avigan, MD Beth Israel Deaconess Medical Center
More Information
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Responsible Party: David Avigan, Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00626860    
Other Study ID Numbers: 2001P001112
DCMEL-003-00
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017
Keywords provided by David Avigan, Beth Israel Deaconess Medical Center:
melanoma
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