Recurrent glioblastoma
Conditions
Interventions
This clinical study is an open-label, single-armed, phase I-II study. Three cohorts of 3 subjects each are planned in a dose escalation phase, and 12 additional subjects will be treated at the highes
Sponsors
(1) The University of Tokyo Hospital (2) The IMSUT Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histologically confirmed recurrent glioblastoma that is progressive despite previous or ongoing radiation therapy -Enhancing lesion measures 1.0 cm or larger in diameter on contrast-enhanced MRI within 14 days of G47delta administration -Karnofsky Performance Scale(KPS) >= 70% -Age >= 18 years -Steroids regimen stable for at least 1 week prior to G47delta administration -Willing to use effective barrier birth control for at least 6 months after G47delta administration -Expected survival >= 3 months -Ability to give informed consent
Exclusion criteria
Exclusion criteria: -Previous history or current diagnosis of other cancer except curative cervical cancer in-situ or basal or squamous cell carcinoma of the skin -Previous history of encephalitis, multiple sclerosis or other CNS infection -Known HIV seropositivity -History of alcohol or other drug abuse -Any contraindication for undergoing gadolinium contrast enhanced MRI such as: individuals with pacemakers, infusion pumps, or allergy to MRI contrast media -History or current diagnosis of any medical or psychological condition that might interfere with the subject's ability to participate -Documented extracranial metastases -Multiple intracranial malignant glioma lesions -Tumor involvement that would require ventricular, brainstem, or posterior fossa inoculation or access through a ventricle in order to deliver the study drug -Subependymal or subarachnoidal dissemination -Evidence of active herpes infection -Requires antiviral therapy for HSV at baseline -Active uncontrolled infection that precludes surgery -Uncontrolled or severe medical condition such as heart failure, diabetes mellitus, hypertension, interstitial pneumonia, renal failure, and autoimmune disease -Blood test results outside protocol specified limits -Allergy to anti-HSV drug (acyclovir) -Administration of other clinical study drugs within 30 days of G47delta administration -Immunotherapy (e.g., interferon) within 6 weeks of G47delta administration -Any vaccination within 30 days of G47delta administration -Brain tumor resection within 30 days of G47delta administration -Prior gene therapy or oncolytic virus therapy other than G47delta -Prior history of G47delta treatment or registration to G47delta clinical study -Pregnant or nursing females -Conditions considered inadequate for the subject to be enrolled in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety -Spectrum and frequency of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy -Change in tumor size on MRI -Progression free survival -Overall survival | — |
Countries
Japan
Outcome results
None listed