A phase I/IIa study of Ad-SGE-REIC-NS in patient with recurrent malignant glioma

JRCT ID: jRCT2063190013

Registered date:05/08/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: reccurent malignant glioma
• Date of first enrollment: 24/09/2019
• Target sample size: 18
• Study type: Interventional

Intervention(s)

Ad-SGE-REIC-NS will be injected twice intra-tumorally at intervals of 14 days to patients with recurrent malignant glioma.
The contrast-enhanced MRI-guided injection of Ad-SGE-REIC-NS will be done to patients undergoing burr hole surgery under local or general anesthesia by the assistance of stereotactic surgical equipment or navigation system
Dose will be escalated as follows:
Level 1 3.0X10^10vp
Level 2 1.0X10^11vp
Level 3 3.0X10^11vp

Outcome(s)

Primary Outcome

1. Safety :
1) Adverse Effect
2) Physical Examination
3) Vital Signs (including blood pressure, pulse, and temprature)
4) A 12-lead Electrocardiogram
5) Chest X-ray
6) Laboratory Assessment (Hematology, Serum Chemistry and Urinalysis)
2. Dose Limiting Toxicity (DLT)
3. Maximum Tolerated Dose (MTD)

Secondary Outcome

1. Efficacy :
1) Antitumor Efficacy [Objective Responce Rate (ORR)]
2) Immunological Assessment

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

1) Has been histologically confirmed to be WHO grade 3 or 4, and recurrence or growth of tumor has been recognized in spite of standard treatment.
2) MRI brain image measured within 14 days prior to the administration of Ad-SGE-REIC-NS is more than 1.0cm both in major and minor axis.
3) Karnofsky Performance Scale (KPS) measured within 14 days prior to the administration of Ad-SGE-REIC-NS is 60% or more.
4) The patient's age upon enrollment is over 18 and under 80 years.
5) The administration of steroid (60mg equivalent of prednisolone) is allowed, but the dose should be stable within 7 days prior to the administration of Ad-SGE-REIC-NS.
6) Life expectancy should be more than 3 months.
7) The function of major organs should be normal and, in principle, the results of checkup examination conducted within 14 days prior to the administration of Ad-SGE-REIC-NS should fulfill the following criteria.
(1)Neutrophil >= 1.0 x 10^3/microL.
(2)Hemoglobin >= 9.0g/dL.
(3)Platelet >= 100 x 10^3/microL.
(4)Leucocyte>= 2.0 x 10^3/microL.
(5)AST/ALT < 4 times of upper limit of standard value
(6)PT-INR or APTT < 1.3 times of upper limit of standard value
(7)Creatinine <= 1.7mg/dL..
8) Must agree to use an acceptable method of birth control during the period of clinical study.
9) Willing and able to provide written informed consent prior to undergoing any study-specific procedures.

Exclude criteria

1) Has received chemotherapy (other than gliadel wafer therapy), immunotherapy or any other therapy including investigational drug treatment and resection of glioma within 28 days prior to the administration of Ad-SGE-REIC-NS. When Temozolomide is prescribed, however, it can be administered until the day before the Ad-SGE-REIC-NS therapy starts.
2) Has received radiotherapy within 90 days prior to the administration of Ad-SGE-REIC-NS.
3) Has extracerebral metastasis or more than 2 extracerebral malignant glioma.
4) Has to be injected in brain ventricle or brain stem, or through brain ventricles.
5) Has subependymoma or subarachnoidal disseminated cancer.
6) Has considered other malignancies to be cured within 3 years.
7) Has contraindication to MRI examination, such as allergic reaction to MRI contrast media.
8) Has HBsAg antibody positivity, or HCV antibody or RNA positivity
9) Has HIV antibody positivityor with previous history of HIV.
10) Has active bacterial, fungal and virus infection (except for hepatitis B and C) or active double cancer.
11) Has a history of interstitial pneumonia.
12) Has a history of angina, heart failure or heart attack within 1 year.
13) Has a history of hypersensitivity to the test drug or any other drug used for the trial including pretreatment.
14) Has uncontrolled diabetes.
15) Requires immunosuppressive treatment except for systemic corticosteroid treatment.
16) Has a history of cerebritis, multiple sclerosis, central neurological infectious disease and addiction to alcohol or drugs, or has addiction to alcohol or drugs.
17) Women during pregnancy, women of childbearing potential or breast-feeding women.
18) Any patient judged inadequate to enroll in the trial by a doctor in charge.

Related Information

• Primary Sponsor: Fujii Kentaro
• Secondary Sponsor: Japan Agency for Medical Research and Development (AMED)
• Source(s) of Monetary Support: Momotaro-Gene Inc.