A Phase I Trial Combining Decitabine and Vaccine Therapy for Patients With Relapsed Neuroblastoma and Sarcoma.

NCT01241162 Phase 1 COMPLETED

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.

Details

Lead sponsor	University of Louisville
Phase	Phase 1
Status	COMPLETED
Enrolment	19
Start date	2010-08
Completion	2016-10

Conditions

• Neuroblastoma
• Ewings Sarcoma
• Osteogenic Sarcoma
• Rhabdomyosarcoma
• Synovial Sarcoma

Interventions

• Autologous dendritic cell vaccine with adjuvant

Primary outcomes

• Tolerance of study treatment — 2 years
  Tolerance to DAC, at at least 50% dosing, and 3 of the 4 planned vaccinations during the first two cycles.

Countries

United States