University of Louisville, Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, 40202, United States
NCT Number: NCT01241162
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.
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Notify Me1 year–24 year
All sexes
Interventional
Phase 1
Louisville, Kentucky, 40202, United States
For vaccine production, mature DC will be pulsed with overlapping peptides mixes derived from full-length NY-ESO-1, MAGE-A1, and MAGE-A3.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: Decitabine (trade name Dacogen or 5-aza-2'-deoxycytidine/DAC, Hiltonol
Time frame: 2 years
Tolerance to DAC, at at least 50% dosing, and 3 of the 4 planned vaccinations during the first two cycles.
Time frame: 2 years
Assessment of tumor responses--complete or partial remission, stable disease, and disease progression--by CT/PET/MIBG or MRI after cycles 2 and 4.
Time frame: 2 years
Assessment of post-vaccination T cell responses to MAGE-A1, MAGE-A3, and NY-ESO-1 by immunoassays.
University of Louisville
Other
A Phase I Trial Combining Decitabine and Vaccine Therapy for Patients With Relapsed Neuroblastoma and Sarcoma.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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