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Clinical Trials

Topic   Neurology
Title   A Randomized, Multicenter, Phase 2 Study of DSP- 7888 Dosing Emulsion in Combination with Bevacizumab versus Bevacizumab Alone in Patients with Recurrent or Progressive Glioblastoma following Initial Therapy
Summary   This study focuses on the new vaccine drug DSP-7888 which is administered by intradermal injection. Patients enrolled in the study will receive one dose of DSP-788 every week plus a dose of Bevacizumab (Avastin) IV infusion every two weeks for the first four weeks of the study. If patients experience no unacceptable side effects than they will continue to a Consolidation Phase in which patients will receive one dose of DSP-7888 plus a dose of Bevacizumab every two weeks for the next 20 weeks. If the patient does not experience unacceptable side effects they will continue to the Maintenance Phase of the study. During the Maintenance Phase patients will receive one dose of DSP-7888 every 28 days plus a dose of Bevacizumab every two weeks for as long as the doctor believes the therapy is helping. If at any point the patient experiences unacceptable side effects their participation in the study will end.
Description   The main purpose of the study is to compare treatment with DSP-7888 in combination with Bevacizumab versus Bevacizumab alone in patients with glioblastoma.
IRB Number   17017
Inclusion/Notes   To be eligible for this study, patients must meet several criteria, including but not limited to the following: Must be 18 years or older with a diagnosis of supratentorial GBM (Grade 4 astrocytoma) and evidence of first recurrence or progression of GBM following primary therapy consisting of surgery (biopsy or resection) and chemoradiation; patients may have undergone a second debulking surgery following initial recurrence or progression. Patients whose tumors are O6-methyl-guanyl-methyl-transferase (MGMT) methylated-promoter negative need not have received chemotherapy in the past to be eligible. Must have the following Human leukocyte antigen (HLA) type HLA-A*02:01, HLA-A*02:06, or HLA-A*24:02. Patients must be at least 12 weeks from the completion of prior RT in order to discriminate pseudo-progression of disease from progression. Patients must be at least 4 weeks from the completion of prior systemic or intracranial chemotherapy.
Status   Open
Start Date   03/29/2017
Principal Name   Dr. Paul Duic
Contact Name   Lisa Chen
Fax   516-663-1081
Current Trial Type   Interventional
Phone   516-663-4895
Alternate Phone   516-663-3115