Loading clinical trials...

Combination of PVSRIPO and Atezolizumab for Adults With Recurrent Malignant Glioma | Clinical Trials | Clareo Health

WITHDRAWNPHASE1/PHASE2

Combination of PVSRIPO and Atezolizumab for Adults With Recurrent Malignant Glioma

A Phase 1b/2 Trial of PVSRIPO in Combination With Atezolizumab in Recurrent WHO Grade IV Malignant Glioma

NCT03973879•Darell Bigner

Summary

This study evaluates the safety of PVSRIPO treatment in combination with Atezolizumab in patients with WHO grade IV malignant glioma. All patients will receive a single PVSRIPO infusion followed by atezolizumab infusions every three weeks for up to two years.

Detailed Description

The purpose of this phase1b/2 study of atezolizumab in combination with oncolytic polio/rhinovirus recombinant (PVSRIPO) in patients with recurrent World Health Organization (WHO) grade IV malignant glioma is to assess the safety of the combination of PVSRIPO + atezolizumab, as well as describe the survival of patients receiving this novel therapy combination. Patients will receive an intratumoral infusion of PVSRIPO followed by atezolizumab treatment with possible surgical resection after the first atezolizumab treatment at the discretion of the treating neurosurgeon.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have a recurrent supratentorial WHO grade IV malignant glioma based on imaging studies with measurable disease (≥ 1 cm and ≤ 5.5 cm of contrast-enhancing tumor). Prior histopathology consistent with a WHO grade IV malignant glioma confirmed by the study pathologist, Roger McLendon, or his designate. Assuming patient meets all other criteria, the treating neurosurgeon must confirm placement of infusion catheter tip can occur ≥ 1cm from ventricles and that procedures can be completed per their medical judgement and in keeping with the protocol, when considering individual lesion characteristics including location relative to eloquent brain function.
•Patient or partner(s) meets one of the following criteria:
•1. Non-childbearing potential (i.e. not sexually active, physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile, or any male who has had a vasectomy). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Postmenopausal for purposes of this study is defined as 1 year without menses.; or
•2. Childbearing potential and agrees to use one of the following methods of birth control: approved hormonal contraceptives (e.g. birth control pills, patches, implants, or infusions), an intrauterine device, or a barrier method of contraception (e.g. a condom or diaphragm) used with spermicide.
•Age ≥ 18 years of age at the time of entry into the study
•Karnofsky Performance Score (KPS) ≥ 70%
•Prothrombin and Partial Thromboplastin Times ≤ 1.2 x normal prior to biopsy
•Total bilirubin, serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), alkaline phosphatase ≤ 2.5 x normal prior to biopsy
•Neutrophil count ≥ 1000 prior to biopsy
•Hemoglobin ≥ 9 prior to biopsy
+7 more criteria

Exclusion Criteria

•Females who are pregnant or breast-feeding
•Patients with an impending, life-threatening cerebral herniation syndrome, based on the assessment of the study neurosurgeons or their designate
•Patients with severe, active co-morbidity, defined as follow:
•1. Patients with an active infection requiring intravenous treatment or having an unexplained febrile illness (Tmax \> 99.5°F/37.5°C)
•2. Patients with known immunosuppressive disease or known human immunodeficiency virus infection
•3. Patients with unstable or severe intercurrent medical conditions such as severe heart disease (New York Heart Association Class 3 or 4)
•4. Patients with known lung (forced expiratory volume in the first second of expiration (FEV1) \< 50%) disease or uncontrolled diabetes mellitus
•5. Patients with albumin allergy
•6. Patients with gadolinium allergy
•Patients with a previous history of neurological complications due to PV infection
+16 more criteria

Key Dates

Start Date

February 1, 2020

Primary Completion Date

January 1, 2024

Completion Date

January 1, 2024

Last Updated

February 11, 2020

Conditions

Malignant Glioma

Interventions

PVSRIPO

BIOLOGICAL

Atezolizumab

DRUG

A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)

NCT05099003

Malignant Glioma

View study

RECRUITINGEARLY_PHASE1

Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma

NCT05717153

Diffuse GliomaMalignant Glioma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Combination of PVSRIPO and Atezolizumab for Adults With Recurrent Malignant Glioma

Inclusion Criteria

Exclusion Criteria

A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)

Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma

BGB-290 and Temozolomide in Treating Isocitrate Dehydrogenase (IDH)1/2-Mutant Grade I-IV Gliomas

Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)

Whole Brain Radiation Therapy With Standard Temozolomide Chemo-Radiotherapy and Plerixafor in Treating Patients With Glioblastoma

Safety and Tolerability of Carboxyamidotriazole Orotate (CTO) in Solid Tumors or With Temodar® in Glioblastoma or Other Recurrent Malignant Gliomas or in Combination With Temodar® and Radiation Therapy for Patients With Newly Diagnosed Glioblastoma and Malignant Gliomas