Decitabine Followed by a Cancer Antigen Vaccine for Patients With Neuroblastoma and Sarcoma
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|ClinicalTrials.gov Identifier: NCT01241162|
Recruitment Status : Completed
First Posted : November 16, 2010
Last Update Posted : May 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma Ewings Sarcoma Osteogenic Sarcoma Rhabdomyosarcoma Synovial Sarcoma||Biological: Autologous dendritic cell vaccine with adjuvant||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial Combining Decitabine and Vaccine Therapy for Patients With Relapsed Neuroblastoma and Sarcoma.|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
Experimental: Single arm study
Biological/Vaccine: Autologous dendritic cell vaccine with adjuvant
Biological: Autologous dendritic cell vaccine with adjuvant
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
- Tolerance of study treatment [ Time Frame: 2 years ]Tolerance to DAC, at at least 50% dosing, and 3 of the 4 planned vaccinations during the first two cycles.
- Tumor Response [ 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.
- Immune Response [ Time Frame: 2 years ]Assessment of post-vaccination T cell responses to MAGE-A1, MAGE-A3, and NY-ESO-1 by immunoassays.
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): NCT01241162
|United States, Kentucky|
|University of Louisville, Kosair Charities Pediatric Clinical Research Unit|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Kenneth G Lucas, MD||University of Louisville, Kosairs Charities Pediatric Clinical Research Unit|