Status:
COMPLETED
Decitabine Followed by a Cancer Antigen Vaccine for Patients With Neuroblastoma and Sarcoma
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
Solving Kids' Cancer
Conditions:
Neuroblastoma
Ewings Sarcoma
Eligibility:
All Genders
1-24 years
Phase:
PHASE1
Brief 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...
Detailed Description
For vaccine production, mature DC will be pulsed with overlapping peptides mixes derived from full-length NY-ESO-1, MAGE-A1, and MAGE-A3.
Eligibility Criteria
Inclusion
- 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 post-transplant.
- Age: Patients must be 1 - \< 25 years of age when registered on study.
- Organ Function Requirements: All patients must have adequate organ function defined as:
- 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
- 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, Hiltonol, or any vaccine component.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01241162
Start Date
August 1 2010
End Date
October 1 2016
Last Update
May 9 2017
Active Locations (1)
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1
University of Louisville, Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, United States, 40202