Chemotherapy and Radiation Therapy for the Treatment of IDH Wildtype Gliomas or Non-histological (Molecular) Glioblastomas

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• Historical grade II and III gliomas IDH wildtype gliomas by including; diffuse astrocytoma, anaplastic astrocytoma, oligodendroglioma, anaplastic oligodendroglioma, oligoastrocytoma, anaplastic oligoastrocytoma
• IDH wildtype gliomas (molecularly defined high grade glioma or molecularly defined glioblastoma [GBM])
• History & physical exam, and Karnofsky performance status (KFS) of >= 70 within 30 days prior to enrollment
• Post-operative magnetic resonance imaging (MRI) with contrast is mandatory and necessary for radiation therapy (RT) planning
• Thin-slice (< 1.5 mm) three-dimensional (3D) T1 pre and post contrast and axial T2/fluid-attenuated inversion recovery (FLAIR) sequences for planning purposes are highly encouraged to obtain.
• Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (within 60 days prior to registration)
• Platelets >= 100,000 cells/mm^3 (within 60 days prior to registration)
• Hemoglobin >= 10.0 g/dl (within 60 days prior to registration) (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is acceptable)
• Bilirubin =< 1.5 upper limit of normal (ULN) (within 60 days prior to registration)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN (within 60 days prior to registration)
• Blood urea nitrogen (BUN) < 30 mg/dl (within 60 days prior to registration)
• Serum creatinine < 1.5 mg/dl (within 60 days prior to registration)

You cannot join if

• Definitive clinical or radiologic evidence of metastatic disease; if applicable
• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years. (For example, carcinoma in situ of the breast, oral cavity or cervix are permissible)
• Prior cranial radiotherapy or radiotherapy to the head and neck where potential field overlaps would exist
• Prior chemotherapy or radiotherapy for any brain tumor
• Histologic diagnosis of gliosarcoma World Health Organization (WHO grade IV) or pilocytic astrocytoma (WHO grade I)
• Multicentric glioblastoma
• Leptomeningeal disease
• Inability to undergo MRI with and without contrast
• Severe, active co-morbidity defined as follows:
• Unstable angina or congestive heart failure requiring hospitalization within 6 months prior to enrollment
• Transmural myocardial infarction within the last 6 months prior to registration. Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of >= 2 mm using the analysis of an electrocardiogram (EKG) performed within 28 days prior to registration. (Note: EKG to be performed only if clinical suspicion of cardiac issue)
• New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to registration
• Serious and inadequately controlled arrhythmia at step 2 registration
• Serious or non-healing wound, ulcer or bone fracture or history of abdominal fistula, intra-abdominal abscess requiring major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to registration, with the exception of the craniotomy for surgical resection
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
• Human immunodeficiency virus (HIV) positive with CD4 count < 200 cells/microliter. Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is because the treatments involved in this protocol may be significantly immunosuppressive with potentially fatal outcomes in patients already immunosuppressed
• Any other severe immunocompromised condition
• Active connective tissue disorders, such as lupus or scleroderma that in the opinion of the treating physician may put the patient at high risk for radiation toxicity
• End-stage renal disease (i.e., on dialysis or dialysis has been recommended)
• Any other major medical illnesses or psychiatric treatments that in the investigator's opinion will prevent administration or completion of protocol therapy

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

locally-acting temozolomide formulation SI-053. A powder for gel formulation containing the cytotoxic alkylating agent temozolomide (TMZ), an imidazotetrazine derivative of the alkylating agent dacarbazine, immobilized on the polymeric carrier dextran phosphate, with potential antineoplastic activity. The TMZ formulation SI-053 forms a viscous gel upon reconstitution in water. Upon local intraoperative administration of the gel into the cavity that is formed after resection of the brain tumor, SI-053 allows for local and prolonged action of TMZ. TMZ is converted at physiologic pH to the short-lived active compound 5-(3-methyl-(triazen-1-yl)-imidazole)-4-carboxamide (monomethyltriazenoimidazole carboxamide; MTIC). The cytotoxicity of MTIC is due to methylation of DNA, particularly at the O6 and N7 positions of guanine residues, resulting in cell cycle arrest, inhibition of DNA replication and the induction of apoptosis. The local administration of TMZ allows for the local destruction of the remaining tumor cells immediately after the removal of the tumor and may prevent the recurrence of tumor growth while having no severe systemic toxicity. NCI Drug Dictionary

Treatments listed in the registry

• Quality-of-Life Assessment (Other): Ancillary studies
• Questionnaire Administration (Other): Ancillary studies
• Radiation Therapy (Radiation): Undergo radiation therapy
• Temozolomide (Drug): Given PO

Na · Single Group · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• questionnaires: Part of the study plan
• radiation: Part of the study plan

Main goals

• Progression free survival (PFS) (From start of treatment until objective tumor progression or death, whichever happens first, assessed up to 52 months)

Other goals

• Overall survival (OS) rate

Planned enrollment: 40 (estimated).

• M D Anderson Cancer Center, Houston, Texas

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT04623931
• NCI Drug Dictionary: C1244

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Jul 15, 2026. Public record; not medical advice.