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Protocol No. UW17071

Principal Investigator Robins, H. Ian

Phase II

Age Group Adult

Scope National

Sponsor Type Industry

Title Randomized, Multicenter, Phase 2 Study of DSP-7888 Dosing Emulsion in Combination with Bevacizumab Alone in Patients with Recurrent or Progressive Glioblastoma following Initial Therapy

Objective The main purpose of this study is to compare the effectiveness of treatment with DSP-7888 in combination with Bevacizumab versus Bevacizumab alone in patients with your type of cancer. Bevacizumab has been approved by the FDA (U.S. Food and Drug Administration) to treat GBM. The chance of assignment to each treatment is 1:1. You will be selected by random (like tossing a coin) to receive either DSP-7888 plus Bevacizumab or bevacizumab alone during the study

Description Phase II trial of DSP-7888 + Bevacizumab versus bevacizumab alone for recurrent Glioblastoma

Key Eligibility Inclusion Criteria Patients must fulfill all the following requirements:
  • Histologically confirmed diagnosis of supratentorial GBM (Grade 4 astrocytoma)
  • Radiographic 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) methylatedpromoter negative need not have received chemotherapy in the past to be eligible
  • Human leukocyte antigen type HLA-A*02:01, HLA-A*02:06, or HLA-A*24:02
  • Age greater than or equal to 18
  • KPS score of greater than or equal to 60
  • Men and women of childbearing potential must agree to use a reliable method of contraception
  • Patient s left ventricular ejection fraction (LVEF) greater than 40%
  • Patient has a resting pulse oximetry of 90% or higher
    Exclusion Criteria:
  • Prior therapy with Bevacizumab
  • Any anti-neoplastic therapy, including RT, for first relapse or recurrence
  • Evidence of leptomeningeal spread of tumor or any history, presence, or suspicion of metastatic disease extracranially
  • Evidence of impending herniation on imaging
  • The need for systemic glucocorticoids in doses in excess of 4 mg/day of dexamethasone or in comparable doses with other glucocorticoids
  • Pregnant or lactating females
  • Patients with active autoimmune diseases within 2 years of enrollment into the study including, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, Sjogren s syndrome, Wegener s granulomatosis, ulcerative colitis, Crohn s disease, myasthenia gravis, Graves disease, or uveitis except for psoriasis not requiring systemic therapy, vitiligo or alopecia areata, or hypothyroidism; if an autoimmune condition has been clinically silent for 12 months or greater, the patient may be eligible for enrollment
  • Patients with primary immunodeficiency diseases
  • Known history of human immunodeficiency virus (HIV) infection, active hepatitis B, or untreated hepatitis C; patients who have completed a course of anti-viral treatment for hepatitis C are eligible
  • Patient has a medical history of frequent ventricular ectopy, e.g., non-sustained ventricular tachycardia (VT)
  • Significant cardiovascular disease, including New York Hospital Association Class III or IV congestive heart failure, myocardial infarction within 6 months of enrollment, unstable angina, poorly controlled cardiac arrhythmias, or stroke within the preceding 6 months
  • Any other uncontrolled inter-current medical condition, including systemic fungal,bacterial, or viral infection; uncontrolled hypertension; diabetes mellitus; or chronic obstructive pulmonary disease requiring 2 or more hospitalizations in the preceding 12 months
  • Patient has a QTcF (QT corrected based on Fridericia s equation) interval > 480 msec or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) at screening. (Patients with bundle branch block and a prolonged QTc interval should be reviewed by the Medical Monitor for potential inclusion
  • Patient has dyspnea at rest or has required supplemental oxygen within 2 weeks of study enrollment

  • Applicable Disease Sites Brain/Central Nervous System

    Status Open

    Participating Institutions UW Hospital and Clinics