A Study of the Treatment of Recurrent Malignant Glioma With rQNestin34.5v.2

Summary

This research study is evaluating an investigational drug, an oncolytic virus called rQNestin34.5v.2. This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug as a possible treatment for this diagnosis of recurrent or progressive brain tumor.

Conditions

• Malignant Glioma of Brain
• Astrocytoma
• Malignant Astrocytoma
• Oligodendroglioma
• Anaplastic Oligodendroglioma of Brain (Diagnosis)
• Mixed Oligo-Astrocytoma
• Ependymoma
• Ganglioglioma
• Pylocytic/Pylomyxoid Astrocytoma
• Brain Tumor
• Glioma
• Brain Cancer
• Glioblastoma
• Glioblastoma Multiforme

Interventions

DRUG

rQNestin

rQNestin is an oncolytic viral vector. It is administered via intratumoral injection during biopsy surgery.

DRUG

Cyclophosphamide

Cyclophosphamide is an immunomodulating agent. It is administered intravenously in a single dose 2 days (+/- 6 hrs) before surgery.

PROCEDURE

Stereotactic biopsy

In both arms, subjects will undergo standard of care stereotactic biopsy in the intraoperative MRI operating room. The stereotactic needle will be placed stereotactically into the tumor bed using intraoperative MRI guidance to collect the biopsy, and again to administer the rQNestin oncolytic virus.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• Candel Therapeutics, Inc.

  collaborator INDUSTRY

• Dana-Farber Cancer Institute

  lead OTHER

Principal Investigators

• E. Antonio Chiocca, MD, PhD · Brigham and Women's Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-18

Primary Completion

2027-01-31

Completion

2028-01-31

FDA Drug

Yes

Countries

• United States

Study Locations