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|NCT02332889 : Phase I/II: Decitabine/Vaccine Therapy in Relapsed/Refractory Pediatric High Grade Gliomas/Medulloblastomas/CNS PNETs|
|Phase||Phase 1/Phase 2|
|Ages||Min: 2 Years Max: 25 Years|
Criteria for enrollment:
- Relapsed medulloblastoma, CNS PNET, or high grade glioma. Confirmatory biopsy is
required at time of initial diagnosis.
- Because of rapid clinical progression and decline at time of relapse in patients with
grade IV gliomas and DIPGs, and the 4-6 weeks required to develop vaccine, patients
with these tumors will be eligible to enroll and have DCs harvested and stored at the
time of diagnosis, but will not be treated with vaccine until time of relapse.
- Age: Patients must be 2 to 25 years of age.
Criteria for treatment:
- The patient must have experienced relapsed, progressive, or refractory disease.
- The patient may have gross tumor that has been treated with chemotherapy or radiation
prior to study treatment.
- The patient must have received standard therapy for their tumor.
- The patient must be at least 90 days from primary radiotherapy.
- Hematologic Function: ANC: 1000/uL; Platelet count: 75,000/uL.
- Renal Function: Creatinine clearance or radioisotope GFR 70ml/min/1.73 m2 .
- Cardiac Function: Patient must have normal cardiac function documented by:
- Ejection fraction (>55%) documented by echocardiogram or radionuclide MUGA evaluation
- Fractional shortening (?28%) documented by echocardiogram
- Liver Function: Total bilirubin 1.5x normal for age, and SGPT (ALT) and SGOT (AST) 3x
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/Karnofsky performance scale > 50, ECOG < or = 2 (Appendix I).
- 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 high doses of systemic corticosteroids or concurrent
chemotherapy at the time of beginning study treatment. (Maximum dose of dexamethasone
allowed is 0.1mg/kg/day not to exceed 4mg/day.)
- Patient has a known systemic hypersensitivity to DAC, Hiltonol, or any vaccine
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02332889
| Link to official Clinicaltrials.gov listing