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

NCT05030298 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: MC21071020-013209
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Malignant Glioma

Outcome Measures

Primary Outcomes (3)

• Proportion of patients experiencing any acute grade 3 or greater unplanned adverse event

  Assessed per Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. The toxicity rate will be estimated using a binomial estimator and a one-sided 95% confidence interval (CI) of the rate will be computed with normal approximation.

  Up to 4 weeks postoperative radiotherapy

• Acute clinical toxicity

  Assessed per CTCAE v5.0. The maximum grade for each type of acute adverse events will be recorded for each patient. Data will be summarized as frequencies and relative frequencies by treatment arm. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Rates will be compared between arms using chi-squared tests.

  Up to 4 weeks postoperative radiotherapy

• Maximum tolerated dose (MTD) of preoperative radiosurgery

  After the trial is completed, the MTD will be based on isotonic regression. The dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate will be selected as the MTD. If there are ties, the higher dose level will be selected when the isotonic estimate is lower than the target toxicity rate; and the lower dose level will be selected when the isotonic estimate is greater than or equal to the target toxicity rate.

  Up to 4 weeks postoperative radiotherapy

Secondary Outcomes (3)

• Radiographic tumor control

  At 12 months post-surgery

• Rate of pseudoprogression

  At first post radiation scan

• Overall survival

  At 12 months post-surgery

Other Outcomes (1)

• Tumor tissue evaluation of tumor changes

  Up to 14 days Post-radiosurgery

Study Arms (1)

Treatment (stereotactic biopsy, radiosurgery, surgery)

EXPERIMENTAL

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.

Radiation: Radiation Therapy; Radiation: Radiosurgery; Procedure: Stereotactic Biopsy; Drug: Temozolomide; Procedure: Tumor Treating Fields Therapy; Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection; Procedure: Biopsy; Procedure: Therapeutic Conventional Surgery

Interventions

Radiation Therapy RADIATION

Undergo radiation therapy

Also known as: Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Treatment (stereotactic biopsy, radiosurgery, surgery)

Radiosurgery RADIATION

Undergo radiosurgery

Also known as: Ablation, Radiosurgical, Radiation Surgery

Treatment (stereotactic biopsy, radiosurgery, surgery)

Stereotactic Biopsy PROCEDURE

Undergo MRI-guided stereotactic biopsy

Treatment (stereotactic biopsy, radiosurgery, surgery)

Temozolomide DRUG

Drug

Also known as: CCRG-81045, Gliotem, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831, Methazolastone, RP-46161, SCH 52365, Temcad, Temizole, Temodal, Temodar, Temomedac, TMZ

Treatment (stereotactic biopsy, radiosurgery, surgery)

Tumor Treating Fields Therapy PROCEDURE

Undergo TTF

Also known as: Alternating Electric Field Therapy, TTF, TTFields

Treatment (stereotactic biopsy, radiosurgery, surgery)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, nuclear magnetic resonance imaging, sMRI, Structural MRI

Treatment (stereotactic biopsy, radiosurgery, surgery)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (stereotactic biopsy, radiosurgery, surgery)

Biopsy PROCEDURE

Undergo biopsy

Also known as: BIOPSY_TYPE, Bx

Treatment (stereotactic biopsy, radiosurgery, surgery)

Therapeutic Conventional Surgery PROCEDURE

Undergo surgery

Treatment (stereotactic biopsy, radiosurgery, surgery)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Glioma

Interventions

Radiotherapy; Radiation; Radiosurgery; Temozolomide; Magnetic Resonance Spectroscopy; Specimen Handling; Biopsy

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Phenomena; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Spectrum Analysis; Chemistry Techniques, Analytical; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical

Study Officials

• Daniel M. Trifiletti, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The first four patients will be treated by standard of care and all subsequently enrolled patients will undergo preoperative radiosurgery by dose escalation schedule.

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: September 1, 2021
• Study Start: May 23, 2023
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (2)