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| Name | Class |
|---|---|
| Solving Kids' Cancer | OTHER |
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This treatment study for relapsed high-risk neuroblastoma, Ewings sarcoma, osteogenic sarcoma, rhabdomyosarcoma or synovial sarcoma involves an autologous cancer testis (CT) antigen specific dendritic cell (DC) vaccine preceded by decitabine as a demethylating chemotherapy.
For vaccine production, mature DC will be pulsed with overlapping peptides mixes derived from full-length NY-ESO-1, MAGE-A1, and MAGE-A3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm study | Experimental | Biological/Vaccine: Autologous dendritic cell vaccine with adjuvant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous dendritic cell vaccine with adjuvant | Biological | Week 1: Decitabine (DAC): 10 mg/m2/day IV (Mon-Fri) Weeks 2 and 3: Vaccine: 3-5 E6 peptide pulsed DC (Mon) Hiltonol applied topically to vaccine site before and after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance of study treatment | Tolerance to DAC, at at least 50% dosing, and 3 of the 4 planned vaccinations during the first two cycles. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response | Assessment of tumor responses--complete or partial remission, stable disease, and disease progression--by CT/PET/MIBG or MRI after cycles 2 and 4. | 2 years |
| Immune Response | Assessment of post-vaccination T cell responses to MAGE-A1, MAGE-A3, and NY-ESO-1 by immunoassays. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth G Lucas, MD | University of Louisville, Kosairs Charities Pediatric Clinical Research Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville, Kosair Charities Pediatric Clinical Research Unit | Louisville | Kentucky | 40202 | United States |
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| ID | Term |
|---|---|
| D009447 | Neuroblastoma |
| D012512 | Sarcoma, Ewing |
| D012516 | Osteosarcoma |
| D012208 | Rhabdomyosarcoma |
| D013584 | Sarcoma, Synovial |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D000277 | Adjuvants, Pharmaceutic |
| D000077209 | Decitabine |
| C019531 | poly ICLC |
| ID | Term |
|---|---|
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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|
| 2 years |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D012509 | Sarcoma |
| D009217 | Myosarcoma |
| D009379 | Neoplasms, Muscle Tissue |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001374 | Azacitidine |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |