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Vaccine Biotherapy of Cancer: Autologous Tumor Cells and Dendritic Cells (DCVaccineMel)

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. Identifier: NCT00948480
Recruitment Status : Completed
First Posted : July 29, 2009
Last Update Posted : July 15, 2016
Information provided by:
Hoag Memorial Hospital Presbyterian

Brief Summary:
This protocol was conducted as a single institution trial at Hoag Cancer Center, Hoag Hospital, Newport Beach, California. It was a single-arm phase II trial in which patients with metastatic melanoma received subcutaneous (s.c.) injections of irradiated autologous tumor cells that had been established as short-term cell lines, in conjunction with their own dendritic cells (DC) and granulocyte macrophage colony-stimulating factor [GM-CSF]. Eligible patients had regionally recurrent and/or distant metastatic cancer.

Condition or disease Intervention/treatment Phase
Metastatic Melanoma Biological: Autologous tumor cells plus dendritic cells Drug: GM-CSF Phase 2

Detailed Description:
Patients were stratified by whether they had no measurable disease [NMD] at the time of treatment (usually because of surgical resection of metastases), or whether they had objectively measurable disease (OMD) by physical examination or radiologic scans per response evaluation criteria in solid tumors (RECIST criteria). Key endpoints were the results of delayed type hypersensitivity (DTH) skin testing to their own irradiated tumor cells, event-free survival [death or disease progression], overall survival, and objective tumor regression in patients who have measurable disease at the time vaccine therapy was initiated. This study was activated in the fall of 2000, and closed to accrual in June 2007.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vaccine Biotherapy Of Cancer: Autologous Tumor Cells and Dendritic Cells as Active Specific Immunotherapy in Patients With Metastatic Melanoma
Study Start Date : October 2000
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma Vaccines

Intervention Details:
  • Biological: Autologous tumor cells plus dendritic cells
    A series of 8 vaccinations are administered over 6 months
  • Drug: GM-CSF
    500 mcg
    Other Name: Sargramostim

Primary Outcome Measures :
  1. event-free survival [death or disease progression] [ Time Frame: 5.5 years after treatment initation ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5.5 years after treatment initation ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Recurrent or metastatic melanoma as defined by stage IV disease (distant metastases), or any recurrent melanoma manifested by lymph node metastases or soft tissue nodules
  • ECOG Performance status of 0-2
  • Satisfactory medical condition for treatment in a phase I-II trial of anticancer therapy
  • Age > 16 years
  • Venous access for leukopheresis procedure to obtain peripheral blood lymphocytes to generate dendritic cells.
  • Serum pregnancy test must be negative for women of childbearing potential.

Exclusion Criteria:

  • Active central nervous system metastases
  • Known autoimmune disease or disease process that involves the use of immunosuppressive therapy.
  • Underlying cardiac disease associated with New York Heart Association class III or IV function, or unstable angina related to atherosclerotic cardiovascular disease.
  • Ongoing transfusion requirements, no significant hepatic or renal dysfunction, creatinine < 2.0 mg/dl, bilirubin < 2.0 mg/dl, albumin > 3.0 mg/dl, hematocrit > 25, platelets > 100,000.
  • Active infection or other active medical condition that could be eminently life threatening, including no active blood clotting or bleeding diathesis.

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 identifier (NCT number): NCT00948480

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United States, California
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92658
Sponsors and Collaborators
Hoag Memorial Hospital Presbyterian
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Principal Investigator: Robert O Dillman, MD Hoag Memorial Hospital Presbyterian
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Robert O. Dillman, MD, Hoag Memorial Hospital Presbyterian Identifier: NCT00948480    
Other Study ID Numbers: DC Melanoma
First Posted: July 29, 2009    Key Record Dates
Last Update Posted: July 15, 2016
Last Verified: July 2016
Keywords provided by Hoag Memorial Hospital Presbyterian:
autologous tumor cell vaccine
metastatic melanoma
sargramostim (GM-CSF)
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Immunologic Factors
Physiological Effects of Drugs