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| ID | Type | Description | Link |
|---|---|---|---|
| HOAG-HCC-06-03 |
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RATIONALE: Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy together with GM-CSF may be an effective treatment for melanoma.
PURPOSE: This randomized phase II trial is studying two different vaccine therapy regimens to compare how well they work when given together with GM-CSF in treating patients with recurrent or metastatic melanoma.
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to measurable disease (yes vs no) and location of disease (distant vs regional). Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients receive irradiated autologous tumor cells subcutaneously (SC) and sargramostim (GM-CSF) SC once weekly for 3 weeks and then once monthly for up to 5 months in the absence of disease progression or unacceptable toxicity. |
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| Arm II | Experimental | Patients receive autologous dendritic cells loaded with irradiated autologous tumor cells SC and GM-CSF SC once weekly for 3 weeks and then once monthly for up to 5 months in the absence of disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous tumor cell vaccine | Biological | Given subcutaneously |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival, progression-free survival, event-free survival, and failure-free survival | ||
| Frequency of immune response as measured by delayed-type hypersensitivity and serologic and cellular assays at baseline and during and after completion of study treatment | ||
| Safety |
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DISEASE CHARACTERISTICS:
Diagnosis of melanoma
Must have an established continuously proliferating cell line expanded to about 200 million cells that is free of stromal cells and contamination
No active CNS metastases
PATIENT CHARACTERISTICS:
Karnofsky performance status (PS) 70-100% OR ECOG PS 0-1
Platelet count > 100,000/mm³
Hematocrit > 30%
Creatinine < 2.0 mg/dL
Bilirubin < 2.0 mg/dL
Albumin > 3.0 mg/dL
No significant hepatic or renal dysfunction
No other invasive cancer within the past 5 years
No active infection or other active medical condition that could be eminently life threatening, including any of the following:
No ongoing transfusion requirement
No underlying cardiac disease associated with known myocardial dysfunction
No unstable angina related to atherosclerotic cardiovascular disease
No known autoimmune disease
Negative pregnancy test
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Robert O. Dillman, MD, FACP | Hoag Memorial Hospital Presbyterian | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92663 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32316978 | Derived | Nistor GI, Dillman RO. Cytokine network analysis of immune responses before and after autologous dendritic cell and tumor cell vaccine immunotherapies in a randomized trial. J Transl Med. 2020 Apr 21;18(1):176. doi: 10.1186/s12967-020-02328-6. | |
| 31406564 | Derived | Dillman RO, Cornforth AN, McClay EF, Depriest C. Patient-specific dendritic cell vaccines with autologous tumor antigens in 72 patients with metastatic melanoma. Melanoma Manag. 2019 May 31;6(2):MMT20. doi: 10.2217/mmt-2018-0010. |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C573235 | FANG vaccine |
| C081222 | sargramostim |
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| sargramostim |
| Biological |
Given subcutaneously |
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| therapeutic autologous dendritic cells | Biological | Given subcutaneously |
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| 22996370 | Derived | Dillman RO, Cornforth AN, Depriest C, McClay EF, Amatruda TT, de Leon C, Ellis RE, Mayorga C, Carbonell D, Cubellis JM. Tumor stem cell antigens as consolidative active specific immunotherapy: a randomized phase II trial of dendritic cells versus tumor cells in patients with metastatic melanoma. J Immunother. 2012 Oct;35(8):641-9. doi: 10.1097/CJI.0b013e31826f79c8. |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |