Residual or recurrent glioblastoma
Conditions
Interventions
Test drug will be administered stereotactically into the tumor of patients with residual or recurrent glioblastoma. The assigned dose will be repeatedly inoculated into the tumor no more than 6 times,
Sponsors
The IMSUT Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histologically confirmed residual or recurrent glioblastoma despite previous radiation therapy and TMZ chemotherapy. -Enhancing lesion measures 1.0 cm or larger in diameter on contrast-enhanced MRI within 14 days of eligibility evaluation. -Karnofsky Performance Scale(KPS) >= 60% -Age >= 18 years -Steroids regimen stable for at least 1 week prior to eligibility evaluation. -Willing to use effective barrier birth control until at least 6 months after final G47delta administration -Expected survival >= 3 months
Exclusion criteria
Exclusion criteria: -Previous history of encephalitis, multiple sclerosis or other CNS infection -Known HIV seropositivity -Any contraindication for undergoing gadolinium contrast enhanced MRI such as: individuals with pacemakers, infusion pumps, or allergy to MRI contrast media -Documented extracranial metastases -Multiple intracranial malignant glioma lesions -Tumor in ventricular system, brainstem, or posterior fossa -Subependymal or subarachnoidal dissemination -Evidence of active herpes infection -Requires antiviral therapy for HSV -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 -Alcohol or other drug abuse -Blood test results outside protocol specified limits -Current diagnosis of active cancers -Allergy to anti-HSV drug (acyclovir) -Administration of other clinical study drugs 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 -Use of bevacizumab within 30 days of G47delta administration -Pregnant or nursing females -Conditions considered inadequate for the subject to be enrolled in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy - One year survival ratio | — |
Countries
Japan
Contacts
Public ContactCenter for Translational Research Center for Translational Research
The IMSUT Hospital Center for Translational Research
Outcome results
None listed