Vaccine Biotherapy of Cancer: Autologous Tumor Cells and Dendritic Cells - Full Text View

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:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Sargramostim

Genetic and Rare Diseases Information Center resources: Carcinoid Tumor Neuroepithelioma

U.S. FDA Resources

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:

A series of 8 vaccinations are administered over 6 months

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 (Child, Adult, Senior)
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

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: 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:

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.


Responsible Party:	Robert O. Dillman, MD, Hoag Memorial Hospital Presbyterian
ClinicalTrials.gov Identifier:	NCT00948480 History of Changes
Other Study ID Numbers:	DC Melanoma
Study First Received:	July 28, 2009
Last Updated:	July 13, 2016
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 Vaccines Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016

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