The Use of Dendritic Cell/Tumor Hybridomas as a Novel Tumor Vaccine in Patients With Advance Melanoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Beth Israel Deaconess Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00626860
First received: February 21, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted
  Purpose

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 Intervention Phase
Metastatic Melanoma
Biological: DC/tumor fusion vaccine
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: The Use of Dendritic Cell/Tumor Hybridomas as a Novel Tumor Vaccine in Patients With Advance Melanoma

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: July 2000
Estimated Study Completion Date: November 2008
Primary Completion Date: January 2002 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: DC/tumor fusion vaccine
    SC vaccinations administered to each patient at 3-week intervals for 2-3 doses
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00626860

Locations
United States, Massachusetts
BIDMC
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Genzyme, a Sanofi Company
Investigators
Principal Investigator: David Avigan, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: David Avigan, MD, BIDMC
ClinicalTrials.gov Identifier: NCT00626860     History of Changes
Other Study ID Numbers: 2001-P-01112/1, DCMEL-003-00
Study First Received: February 21, 2008
Last Updated: February 21, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Beth Israel Deaconess Medical Center:
melanoma

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

ClinicalTrials.gov processed this record on August 19, 2014