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Decitabine Followed by a Cancer Antigen Vaccine for Patients With Neuroblastoma and Sarcoma

NCT01241162 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2017-05-09

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Solving Kids' Cancer

    collaborator OTHER

  • University of Louisville

    lead OTHER

Principal Investigators

  • Kenneth G Lucas, MD · University of Louisville, Kosairs Charities Pediatric Clinical Research Unit

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01241162 on ClinicalTrials.gov