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

Study Description

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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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	56 participants
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

Arms and Interventions

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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

Outcome Measures

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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 ]

Eligibility Criteria

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Ages Eligible for Study:	16 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Dillman RO, Selvan SR, Schiltz PM, McClay EF, Barth NM, DePriest C, de Leon C, Mayorga C, Cornforth AN, Allen K. Phase II trial of dendritic cells loaded with antigens from self-renewing, proliferating autologous tumor cells as patient-specific antitumor vaccines in patients with metastatic melanoma: final report. Cancer Biother Radiopharm. 2009 Jun;24(3):311-9. doi: 10.1089/cbr.2008.0599.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dillman RO, Cornforth AN, Nistor GI, McClay EF, Amatruda TT, Depriest C. Randomized phase II trial of autologous dendritic cell vaccines versus autologous tumor cell vaccines in metastatic melanoma: 5-year follow up and additional analyses. J Immunother Cancer. 2018 Mar 6;6(1):19. doi: 10.1186/s40425-018-0330-1.

Responsible Party:	Robert O. Dillman, MD, Hoag Memorial Hospital Presbyterian
ClinicalTrials.gov Identifier:	NCT00948480 History of Changes
Other Study ID Numbers:	DC Melanoma
First Posted:	July 29, 2009
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:

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms	Neoplasms, Nerve Tissue; Nevi and Melanomas; Vaccines; Immunologic Factors; Physiological Effects of Drugs