Preoperative Radiosurgery for the Treatment of High Grade Glioma, NeoGlioma Trial

Mayo Clinic

Status and phase

Enrolling

Phase 1

Conditions

Malignant Glioma

Treatments

Procedure: Biospecimen Collection

Procedure: Magnetic Resonance Imaging

Procedure: Biopsy

Radiation: Radiation Therapy

Procedure: Stereotactic Biopsy

Radiation: Radiosurgery

Procedure: Tumor Treating Fields Therapy

Drug: Temozolomide

Procedure: Therapeutic Conventional Surgery

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05030298

MC210710

20-013209 (Other Identifier)

NCI-2021-08848 (Registry Identifier)

Details and patient eligibility

About

This phase I trial finds out the possible benefits and/or side effects of radiosurgery before surgery (preoperative) in treating patients with high grade glioma. Radiosurgery uses special equipment to position the patient and precisely give a single large dose of radiation to the tumor. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving pre-operative radiosurgery may improve the odds of brain tumor control and reduce treatment-related side effects.

Full description

PRIMARY OBJECTIVE:

I. To evaluate the feasibility, safety and maximum tolerated dose (MTD) of preoperative radiosurgery in the treatment of patients with biopsy-proven high-grade glioma prior to conventional therapy.

SECONDARY OBJECTIVES:

I. Acute clinical toxicity profile using Common Terminology Criteria for Adverse Events (CTCAE) version 5 (defined as within 4 weeks of completion of postoperative radiotherapy.

II. Radiographic tumor control at 12 months following surgery (per Response Assessment in Neuro-Oncology [RANO] criteria).

III. Rate of pseudoprogression at first post radiation scan (RANO criteria). IV. Overall survival at 12 months following surgery.

CORRELATIVE RESEARCH OBJECTIVE:

I. Evaluation of the tumor repair pathways triggered by radiation, tumor vascular changes, tumor microenvironment immune profiling, cell cultures, and the creation of orthotopic xenograft models for future study.

OUTLINE: This is a dose-escalation study.

Patients undergo magnetic resonance imaging (MRI)-guided stereotactic biopsy. Within 14 days of registration, patients undergo either standard of care surgery or radiosurgery in 1 fraction. Within 14 days, patients who underwent radiosurgery then undergo surgery. Within 4-6 weeks, all patients then receive standard of care radiation therapy over 30 fraction and temozolomide daily with or without tumor treating fields (TTF) at the discretion of the treating neuro-oncologist. Additionally, patients undergo MRI and blood sample collection and optional biopsy throughout the study.

After completion of study treatment, patients are followed up every 2-3 months for 12 months and then every 3 months for up to 3 years after registration.

Enrollment

28 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age >= 18 years
Clear clinical and radiographic evidence of primary high grade glioma (HGG) as judged by the Mayo multidisciplinary neuro-oncology team (World Health Organization [WHO] grade III-IV, including glioblastoma) regardless of IDH and MGMT status
Patients who underwent a previous biopsy confirming high grade glioma are eligible for enrollment
Planned neurosurgical resection of tumor
Judged to not be at risk of significant clinical risk (i.e. herniation) with radiation-induced edema prior to resection
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
Negative pregnancy test done =< 14 days prior to registration, for women of childbearing potential only. Patients over 50 years of age who decline pregnancy testing are still eligible without a pregnancy test.
Ability to complete questionnaire(s) by themselves or with assistance
Provide written informed consent
Willing to receive adjuvant radiotherapy at enrolling institution at the time of registration
Willing to provide tissue and/or blood samples for correlative research purposes

Exclusion criteria

Any of the following:
- Pregnant women
- Nursing women who are unwilling to cease during therapy
- Men or women of childbearing potential who are unwilling to employ adequate contraception
Prior history of cranial radiotherapy
Unwillingness to participate in study
Investigator discretion that enrollment on the study would pose undo harm or risk to the patient
Non-MRI compatible implanted medical device
Use of systemic anti-cancer therapy within the previous 3 months
Medical contraindication to craniotomy and tumor resection
Pathologic confirmation of grade I-II glioma, brain metastasis, or other brain tumor
- Note: Patients with a history of grade I-II glioma are eligible if they have only received surgery as treatment and now there is concern for transformation to grade III-IV tumor
Primary spinal cord glioma or primary brainstem glioma
Residual tumor of excessive volume or eloquent location per investigator discretion
Patients who are unwilling or unable to comply with study procedures

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Sequential Assignment

Masking

None (Open label)

28 participants in 1 patient group

Treatment (stereotactic biopsy, radiosurgery, surgery)

Experimental group

Description:

Patients undergo MRI-guided stereotactic biopsy. Within 14 days of registration, patients undergo either standard of care surgery or radiosurgery in 1 fraction. Within 14 days, patients who underwent radiosurgery then undergo surgery. Within 4-6 weeks, all patients then receive standard of care radiation therapy over 30 fraction and temozolomide daily with or without TTF at the discretion of the treating neuro-oncologist. Additionally, patients undergo MRI and blood sample collection and optional biopsy throughout the study.

Treatment: