Vaccine Biotherapy of Cancer: Autologous Tumor Cells and Dendritic Cells (DCVaccineMel)
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ClinicalTrials.gov Identifier: NCT00948480 |
Recruitment Status :
Completed
First Posted : July 29, 2009
Last Update Posted : July 15, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Melanoma | Biological: Autologous tumor cells plus dendritic cells Drug: GM-CSF | Phase 2 |
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 |

- Biological: Autologous tumor cells plus dendritic cells
A series of 8 vaccinations are administered over 6 months
- Drug: GM-CSF
500 mcgOther Name: Sargramostim
- event-free survival [death or disease progression] [ Time Frame: 5.5 years after treatment initation ]
- Overall survival [ Time Frame: 5.5 years after treatment initation ]

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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.

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
United States, California | |
Hoag Memorial Hospital Presbyterian | |
Newport Beach, California, United States, 92658 |
Principal Investigator: | Robert O Dillman, MD | Hoag Memorial Hospital Presbyterian |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Robert O. Dillman, MD, Hoag Memorial Hospital Presbyterian |
ClinicalTrials.gov 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 |
autologous tumor cell vaccine metastatic melanoma sargramostim (GM-CSF) |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Nerve Tissue Nevi and Melanomas Sargramostim Immunologic Factors Physiological Effects of Drugs |