Neuroblastoma Clinical Trial
Official title:
A Phase I Trial Combining Decitabine and Vaccine Therapy for Patients With Relapsed Neuroblastoma and Sarcoma.
Verified date | May 2017 |
Source | University of Louisville |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 19 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 24 Years |
Eligibility |
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 - < 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 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, Hiltonol, or any vaccine component. |
Country | Name | City | State |
---|---|---|---|
United States | University of Louisville, Kosair Charities Pediatric Clinical Research Unit | Louisville | Kentucky |
Lead Sponsor | Collaborator |
---|---|
University of Louisville | Solving Kids’ Cancer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tolerance of study treatment | Tolerance to DAC, at at least 50% dosing, and 3 of the 4 planned vaccinations during the first two cycles. | 2 years | |
Secondary | Tumor Response | Assessment of tumor responses--complete or partial remission, stable disease, and disease progression--by CT/PET/MIBG or MRI after cycles 2 and 4. | 2 years | |
Secondary | Immune Response | Assessment of post-vaccination T cell responses to MAGE-A1, MAGE-A3, and NY-ESO-1 by immunoassays. | 2 years |
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