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

This study has been completed.
Sponsor:
Information provided by:
Hoag Memorial Hospital Presbyterian
ClinicalTrials.gov Identifier:
NCT00948480
First received: July 28, 2009
Last updated: May 10, 2011
Last verified: May 2011
  Purpose

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 Intervention Phase
Metastatic Melanoma
Biological: Autologous tumor cells plus dendritic cells
Drug: GM-CSF
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: Vaccine Biotherapy Of Cancer: Autologous Tumor Cells and Dendritic Cells as Active Specific Immunotherapy in Patients With Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by Hoag Memorial Hospital Presbyterian:

Primary Outcome Measures:
  • event-free survival [death or disease progression] [ Time Frame: 5.5 years after treatment initation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 5.5 years after treatment initation ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: October 2000
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00948480

Locations
United States, California
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92658
Sponsors and Collaborators
Hoag Memorial Hospital Presbyterian
Investigators
Principal Investigator: Robert O Dillman, MD Hoag Memorial Hospital Presbyterian
  More Information

Publications:
Responsible Party: Robert O. Dillman, MD, Hoag Memorial Hospital Presbyterian
ClinicalTrials.gov Identifier: NCT00948480     History of Changes
Other Study ID Numbers: NCT00012064
Study First Received: July 28, 2009
Last Updated: May 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Hoag Memorial Hospital Presbyterian:
autologous tumor cell vaccine
metastatic melanoma
sargramostim (GM-CSF)

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 September 18, 2014