Trials / Terminated
TerminatedNCT01902771
Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors
A Phase I Study of Dendritic Cell Vaccine Therapy With In Situ Maturation for Pediatric Brain Tumors
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Edward Ziga · Academic / Other
- Sex
- All
- Age
- 1 Year – 29 Years
- Healthy volunteers
- Not accepted
Summary
DC vaccine manufactured and partially matured using our standard operating procedures, developed in collaboration with the HGG Immuno Group, then administered through imiquimod treated skin will be safe and feasible in children with refractory brain tumors. This will result in anti-tumor immunity that will prolong survival of subjects treated and results will be consistent with the outcomes found for subjects treated by HGG Immuno Group investigators. Study treatment will correlate with laboratory evidence of immune activation. Correlative studies will also reveal targets in the immune system which can be exploited to improve response for patients on successor trials.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Dendritic Cell Vaccine | Post-Leukapheresis. Subjects will receive DC Vaccine administered once weekly, via intradermal injection, for 4 weeks for a total of four vaccinations, per study protocol. |
| BIOLOGICAL | Tumor Lysate | Post-DC Vaccine therapy. Up to 1.5 mg of Lysate of tumor per dose administered via intradermal injection at intervals defined by study protocol. |
| OTHER | Imiquimod | Subjects will self-apply Imiquimod topically to each designated vaccine site before and after scheduled administrations of DC Vaccine or Lysate, per study protocol. |
| PROCEDURE | Leukapheresis | Baseline, post-surgery. Subjects will undergo leukapheresis procedure during baseline, after recovery from surgery to collect peripheral blood mononuclear cells (PBMCs) from which dendritic cells will be obtained, per study protocol. |
Timeline
- Start date
- 2013-09-03
- Primary completion
- 2016-10-24
- Completion
- 2017-01-26
- First posted
- 2013-07-18
- Last updated
- 2017-03-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01902771. Inclusion in this directory is not an endorsement.