Olfactory neuroblastoma G47delta trial

JRCT ID: jRCTs033180325

Registered date:18/03/2019

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: Olfactory neuroblastoma
• Date of first enrollment: 12/09/2013
• Target sample size: 10
• Study type: Interventional
• Intervention(s): A replication-competent, recombinant herpes simplex virus type 1 (G47delta) will be administered into the tumor of patients with recurrent or progressive olfactory neuroblastoma. The same dose of G47delta will be inoculated to the remaining tumor every 4 weeks.

Outcome(s)

Primary Outcome

Safety
-Spectrum and frequency of adverse events

Secondary Outcome

Efficacy
-Change in tumor size on MRI
-Progression free survival
-Overall survival

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

A patient will be eligible for inclusion in this study only if all of the following criteria apply.
-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

Exclude criteria

A participant will not be eligible for inclusion in this trial if any of the following criteria apply.
-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

Related Information

• Primary Sponsor: Tanaka Minoru
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000011636