Glioma-immunotherapy with fusions of dendritic and glioma cells.

Phase 2

Recruiting

• Conditions: Malignant glioma

• Registration Number: JPRN-jRCTc030190122
• Lead Sponsor: Akasaki Yasuharu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1)A patient who requires a sugery against brain tumor regarded as malignant glioma (WHO grade 2 or 3 or 4) on an imaging examnination(CT or MRI) of brain.
2) A patient who is 15 year to under 75 year, at the time of entry for this trial.
3)A patient who is able to undergo a collection of peripheral blood mononuclear cells(PBMC) using an apehresis system.
4)A patient who preserves function of major organs, such as hart, liver, kidny, and bone marrow etc, with satisfying the standerds below.
5)A patient who is estimated 2 or less the Performance status(PS) grade.
6)A patient who is expected to be alive for 3 months and more.
7)A patient who has no other cancer.

Exclusion Criteria

1) A patient who has an allergy against biological products
2) A patient who has past or current history of autoimmune disease
3) A patient who is a HBV carrier, testing positive for antibodies of HCV, HIV, and HTLV.
4) A patient who has an immune deficiency for some reasons.
5) A patient who is taking steroids for long time, and is hard to stop them.
6) A patient who has a sever infection.
7) A patient who has a sever respiratory disease(Hugh-Jones Class 3 or more).
8) A patient who has a sever hart disease(NYHA Class 3 or more).
9) A patient who has uncontrolable diabetes.
10) A pregnant or possibility of pregnant woman, and a breastfeeder.
11) A patient who has been registered in other clinical trial.
12) A patient who is judged as unsuitable subject for this trial in some reasons.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) A group of patients with newly diagnosed grade 4 glioma (N-G4): 2-year ovaerall survival (OS) ratio <br>2) A group of patients with newly diagnosed grade 2/3 glioma (N-G2/3): 3-year OS ratio <br>3) A group of patients with recurrent glioma (R): 1-year OS ratio <br># An overall survival time is defined as the time from the date of entry until the date of death.

Secondary Outcome Measures

Name	Time	Method
1) A group of N-GIV: 1-year progression free survival (PFS) ratio <br>2) A group of N-G2/3 glioma: 2-year PFS ratio <br>3) A group of R: 6-month PFS ratio <br># A progression free survival time is defined as the time from the date of entry until the first documented progression in MRI using The Revised Assessment in Neuro-Oncology, or the the first documented progression in the clinical symptom.