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

Status: Recruiting
Phase:
Diagnosis: Pediatric Neuroblastoma
NCT ID: NCT01241162 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-130

 

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.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Children's Hospital Boston

Overall PI:
Rani George, Dana Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

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 post-transplant. - Age: Patients must be 1 - < 18 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 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 component.
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