NCT01803152

Dendritic Cell Vaccine for Children and Adults With Sarcoma

A Phase I Trial of Dendritic Cell Vaccination for Children and Adults With Sarcoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Macarena De La Fuente, MD · Academic / Other
• Sex: All
• Age: 1 Year – 100 Years
• Healthy volunteers: Not accepted

Summary

The purpose if this study is to evaluate an investigational vaccine using patient-derived dendritic cells (DC), a type of white blood cell that helps fight infections in the body, (DC) (a vaccine made out of participants' own cells and tumor) to treat sarcoma.

Conditions

• Sarcoma
• Soft Tissue Sarcoma
• Bone Sarcoma

Interventions

Type	Name	Description
BIOLOGICAL	Dendritic Cells Vaccine	Subjects will receive DC Vaccine administered once weekly, via intradermal injection, for 4 weeks for a total of four vaccinations, per study protocol.
BIOLOGICAL	Lysate of Tumor	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.
DRUG	Gemcitabine	Post-surgery, Leukapheresis and clearance of subject. Gemcitabine 1000 mg/m2 IV will be administered once weekly for 3 weeks per study protocol.
DRUG	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 blood draw via catheter to obtain peripheral blood mononuclear cells (PBMCs) from which Dendritic cells will be obtained.

Timeline

• Start date: 2014-01-06
• Primary completion: 2019-09-10
• Completion: 2024-06-21
• First posted: 2013-03-04
• Last updated: 2024-07-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study