Vaccine Biotherapy of Cancer: Autologous Tumor Cells and Dendritic Cells (DCVaccineMel)
This study has been completed.
Sponsor:
Hoag Memorial Hospital Presbyterian
ClinicalTrials.gov Identifier:
NCT00948480
First Posted: July 29, 2009
Last Update Posted: July 15, 2016
Information provided by:
Hoag Memorial Hospital Presbyterian
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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: | 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 |
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 ]
Secondary Outcome Measures:
- Overall survival [ Time Frame: 5.5 years after treatment initation ]
| 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:
Detailed Description:
-
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
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
Information from the National Library of Medicine
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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
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 ClinicalTrials.gov identifier (NCT number): 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: |
DC Melanoma |
| First Submitted: | July 28, 2009 |
| 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 |