Recurrent olfactory neuroblastoma
Conditions
Interventions
This clinical study is an open-label, single-armed study. A replication-competent, recombinant herpes simplex virus type 1 (G47delta) will be administered into the tumor of patients with recurrent or
Sponsors
IMSUT Hospital, The University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histologically confirmed recurrent olfactory neuroblastoma that is progressive despite previous or ongoing radiation therapy. Subjects with and without distant metastases will be included. -Enhancing lesion measures 1.0 cm or larger in diameter on contrast-enhanced MRI within 14 of G47delta administration -Performance Status(PS) = 0 to 2 -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: -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 -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 -Any vaccination within 30 days of G47delta administration -Tumor resection within 30 days of G47delta administration -Prior gene therapy or oncolytic virus therapy other than G47delta -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
Contacts
Public ContactDivision of Clinical Trial Safety Management Division of Clinical Trial Safety Management
IMSUT Hospital, The University of Tokyo Division of Clinical Trial Safety Management
Outcome results
None listed