RECRUITING

A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM)

Conditions

Adult Glioblastoma High Grade Glioma WHO Grade III or IV Malignant Glioma Immunotherapy Brain Tumor Adult newly diagnosed clinical trial Pediatric brain tumor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective will be to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in (Stratum 1) adult patients with newly diagnosed GBM (MGMT low level or unmethylated in adults only) and (Stratum 2) in pediatric patients with newly diagnosed HGG (pHGG). Funding Source - FDA OOPD

Official Title

A Phase I/II Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM)

Quick Facts

Study Start:2021-12-13

Study Completion:2028-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04573140

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible.) * MGMT Methylated tumors * Gliomatosis Cerebri * Metastases detected below the tentorium or beyond the cranial vault and leptomeningeal involvement. * Recurrent or multifocal malignant gliomas. * Metastatic or leptomeningeal disease * Residual post-surgical disease burden \> 3 cm as defined by longest perpendicular diameter on MRI. * Known HIV, Hepatitis B, or Hepatitis C seropositive. * Known active infection or immunosuppressive disease. * Participants who require corticosteroids above physiologic doses or not weaned to physiologic dosing within 1 week of scheduled vaccination. * Prior chemotherapy or radiosensitizers (including Gliadel wafers) for cancers of the head and neck region, other than TMZ prescribed during radiation for GBM (prior chemotherapy for a different cancer is allowable). * Prior radiotherapy to the head or neck, resulting in overlap of radiation fields. Radiosurgery is not permitted. * Severe, active co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization. * Unstable cardiac arrhythmias, abnormalities, or transmural myocardial infarction within the last 6 months. * Acute bacterial or fungal infection requiring intravenous antibiotics at initiation of XRT/TMZ. * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at initiation of XRT/TMZ. * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects. * Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. * Patients with autoimmune disease requiring medical management with immunosuppressants. * Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy. * Active connective tissue disorders such as lupus or scleroderma that, in the investigator's opinion, place the patient at high risk for radiation toxicity. * Pregnancy or women of childbearing potential and men who are sexually active and who are unwilling or unable to use an acceptable method of contraception for the entire study period; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic. * Women of childbearing potential must not be pregnant or breast-feeding. * Prior history of brachial neuritis or Guillain-Barré syndrome. * Participants who are receiving any other investigational agents or who have been treated on any other therapeutic clinical protocols within 30 days prior to study entry. * Participants who are unwilling or unable to receive treatment and undergo follow-up evaluations * Diffuse intrinsic pontine glioma, brainstem diffuse midline glioma, or BRAFV600E+ * Gliomatosis * Metastatic or leptomeningeal disease * Residual post-surgical disease burden \> 3 cm as defined by longest diameter on MRI. * Known HIV, Hepatitis B, or Hepatitis C seropositive. * Uncontrolled seizure disorder * History of myocarditis * Receipt of any live vaccine within 30 days prior to enrollment * Known active infection or immunosuppressive disease. * Participants with significant renal, cardiac (congestive cardiac failure, myocardial infarction, myocarditis), pulmonary, hepatic or other organ dysfunction. * Participants who are anticipated to require corticosteroids above physiologic doses or not weaned to physiologic dosing within 1 week of scheduled vaccination. * Severe or unstable concurrent medical conditions. * Women must not be pregnant or breast-feeding. * Participants who are receiving any other investigational agents or who have been treated on any other therapeutic clinical protocols within 30 days prior to study entry. * Participants who are unwilling or unable to receive treatment and undergo follow-up evaluations.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible.)
* MGMT Methylated tumors
* Gliomatosis Cerebri
* Metastases detected below the tentorium or beyond the cranial vault and leptomeningeal involvement.
* Recurrent or multifocal malignant gliomas.
* Metastatic or leptomeningeal disease
* Residual post-surgical disease burden \> 3 cm as defined by longest perpendicular diameter on MRI.
* Known HIV, Hepatitis B, or Hepatitis C seropositive.
* Known active infection or immunosuppressive disease.
* Participants who require corticosteroids above physiologic doses or not weaned to physiologic dosing within 1 week of scheduled vaccination.
* Prior chemotherapy or radiosensitizers (including Gliadel wafers) for cancers of the head and neck region, other than TMZ prescribed during radiation for GBM (prior chemotherapy for a different cancer is allowable).
* Prior radiotherapy to the head or neck, resulting in overlap of radiation fields. Radiosurgery is not permitted.
* Severe, active co-morbidity, defined as follows:
* Unstable angina and/or congestive heart failure requiring hospitalization.
* Unstable cardiac arrhythmias, abnormalities, or transmural myocardial infarction within the last 6 months.
* Acute bacterial or fungal infection requiring intravenous antibiotics at initiation of XRT/TMZ.
* Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at initiation of XRT/TMZ.
* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
* Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
* Patients with autoimmune disease requiring medical management with immunosuppressants.
* Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy.
* Active connective tissue disorders such as lupus or scleroderma that, in the investigator's opinion, place the patient at high risk for radiation toxicity.
* Pregnancy or women of childbearing potential and men who are sexually active and who are unwilling or unable to use an acceptable method of contraception for the entire study period; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
* Women of childbearing potential must not be pregnant or breast-feeding.
* Prior history of brachial neuritis or Guillain-Barré syndrome.
* Participants who are receiving any other investigational agents or who have been treated on any other therapeutic clinical protocols within 30 days prior to study entry.
* Participants who are unwilling or unable to receive treatment and undergo follow-up evaluations
* Diffuse intrinsic pontine glioma, brainstem diffuse midline glioma, or BRAFV600E+
* Gliomatosis
* Metastatic or leptomeningeal disease
* Residual post-surgical disease burden \> 3 cm as defined by longest diameter on MRI.
* Known HIV, Hepatitis B, or Hepatitis C seropositive.
* Uncontrolled seizure disorder
* History of myocarditis
* Receipt of any live vaccine within 30 days prior to enrollment
* Known active infection or immunosuppressive disease.
* Participants with significant renal, cardiac (congestive cardiac failure, myocardial infarction, myocarditis), pulmonary, hepatic or other organ dysfunction.
* Participants who are anticipated to require corticosteroids above physiologic doses or not weaned to physiologic dosing within 1 week of scheduled vaccination.
* Severe or unstable concurrent medical conditions.
* Women must not be pregnant or breast-feeding.
* Participants who are receiving any other investigational agents or who have been treated on any other therapeutic clinical protocols within 30 days prior to study entry.
* Participants who are unwilling or unable to receive treatment and undergo follow-up evaluations.

Contacts and Locations

Study Contact

Marcia Hodik

CONTACT

352-273-6971

marcia.hodik@neurosurgery.ufl.edu

Principal Investigator

Elias Sayour, MD, PhD

STUDY_CHAIR

University of Florida

Study Locations (Sites)

UF Health

Gainesville, Florida, 32610

United States

Collaborators and Investigators

Sponsor: University of Florida

Elias Sayour, MD, PhD, STUDY_CHAIR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-13

Study Completion Date2028-09-01

Study Record Updates

Study Start Date2021-12-13

Study Completion Date2028-09-01

Terms related to this study

Keywords Provided by Researchers

Immunotherapy
Brain Tumor
Adult
newly diagnosed
clinical trial
Pediatric brain tumor

Additional Relevant MeSH Terms

Adult Glioblastoma
High Grade Glioma
WHO Grade III or IV Malignant Glioma