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

Phase 1
1 Year
17 Years
Open (Enrolling)
Neuroblastoma, Ewings Sarcoma, Osteogenic Sarcoma, Rhabdomyosarcoma, Synovial Sarcoma

Thank you

Trial Information

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

For vaccine production, mature DC will be pulsed with overlapping peptides mixes derived
from full-length NY-ESO-1, MAGE-A1, and MAGE-A3.

Inclusion Criteria:

- Confirmed diagnosis of relapsed high-risk neuroblastoma,Ewings sarcoma, osteogenic
sarcoma, rhabdomyosarcoma, synovial sarcoma

- Patient may have gross tumor that has been treated with multi-agent chemotherapy
prior study entry, but does not need to have gross tumor prior to study entry.

- Patients must have had a diagnosis of neuroblastoma or sarcoma either by histological
verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow
with increased urinary catecholamines.

- Have received standard chemotherapy and/or SCT, and are at least 6 months

- Age: Patients must be 1 - < 18 years of age when registered on study.

- Organ Function Requirements: All patients must have adequate organ function defined

- Hematological Function: ANC ≥ 500; Platelet count ≥ 75.

- Renal Function: Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 OR A
maximum serum creatinine (mg/dL) based on age/gender as follows: 1YO M&F = 0.6, 2-5YO
M&F = 0.8, 6-9YO M&F = 1, 10-12YO M&F = 1.2, 13-15YO M = 1.5, 13-15YO F = 1.4, 16+ M
= 1.7, 16+ F = 1.4

- Cardiac Function: Patient must have normal cardiac function documented by Ejection
fraction (> 55%) documented by echocardiogram or radionuclide MUGA evaluation OR
Fractional shortening (≥ 28%) documented by echocardiogram

- Liver Function: Total bilirubin ≤ 1.5 x normal for age, AND SGPT (ALT) and SGOT
(AST) ≤ 3 x normal for age.

- Room air pulse oximetry >94%.

- Male and female sexually active patients of reproductive age who wish to participate
must agree to use acceptable contraception.

- Lansky performance scale > 70, ECOG < 2 (Appendix I).

Exclusion Criteria:

- Patient is pregnant.

- Patients with a positive result for any of the following diagnostic tests: Hep B Ag,
Hep B Core Ab, Hep C Ab, HIV-1 Ab, HIV-2 Ab, HTLV-1 Ab, HTLV-2 Ab, RPR.

- Patient has a history of autoimmune disease, specifically inflammatory bowel disease,
systemic lupus erythematosis, or rheumatoid arthritis.

- Patient is receiving concurrent systemic steroid therapy.

- Patient has a known systemic hypersensitivity to DAC, imiquimod, or any vaccine

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tolerance of study treatment

Outcome Description:

Tolerance to DAC, at at least 50% dosing, and 3 of the 4 planned vaccinations during the first two cycles.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Kenneth G Lucas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Louisville, Kosairs Children Charities Pediatric Clinical Research Unit


United States: Food and Drug Administration

Study ID:




Start Date:

August 2010

Completion Date:

August 2013

Related Keywords:

  • Neuroblastoma
  • Ewings Sarcoma
  • Osteogenic Sarcoma
  • Rhabdomyosarcoma
  • Synovial Sarcoma
  • Neuroblastoma
  • Ewings sarcoma
  • osteogenic sarcoma
  • rhabdomyosarcoma
  • synovial sarcoma
  • high-risk
  • relapsed
  • children
  • Neuroblastoma
  • Osteosarcoma
  • Rhabdomyosarcoma
  • Sarcoma, Synovial
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma



University of Louisville, Kosair Children's Charities Pediatric Clinical Research Unit Louisville, Kentucky  40202