Trials / Completed
CompletedNCT01241162
Decitabine Followed by a Cancer Antigen Vaccine for Patients With Neuroblastoma and Sarcoma
A Phase I Trial Combining Decitabine and Vaccine Therapy for Patients With Relapsed Neuroblastoma and Sarcoma.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- University of Louisville · Academic / Other
- Sex
- All
- Age
- 1 Year – 24 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
For vaccine production, mature DC will be pulsed with overlapping peptides mixes derived from full-length NY-ESO-1, MAGE-A1, and MAGE-A3.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Autologous dendritic cell vaccine with adjuvant | 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 |
Timeline
- Start date
- 2010-08-01
- Primary completion
- 2016-10-01
- Completion
- 2016-10-01
- First posted
- 2010-11-16
- Last updated
- 2017-05-09
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01241162. Inclusion in this directory is not an endorsement.