Pre-Radiation Chemotherapy for Newly Diagnosed High-Grade Glioma.

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 80 Years
• SexAll
• Healthy volunteersNo

You may be able to join if

• Pathologic diagnosis of high-grade glioma
• Residual measurable post-operative contrast enhancing tumor
• Lack of urgency in requiring immediate radiation or chemotherapy (mass effect, mid-line shift, herniation, etc.)
• Ability to provide informed consent
• Willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 18-80.
• Karnofsky Performance Status ³70%.
• Patients must have the following organ and marrow functions:
• Absolute neutrophil count ≥1,500/µL Platelets ≥100,000/µL Hemoglobin ≥ 9 g/dL Total bilirubin £ 1.5 × institutional upper limit of normal (ULN), (except for patients with known Gilbert's syndrome who must have normal direct bilirubin) AST (SGOT)/ALT (SGPT) £ 2.5 × ULN Creatinine £ 1.5 × ULN OR Creatinine clearance ≥ 60 mL/min/1.73m2 APTT/PTT ≤ 1.5 × ULN Sodium ≥ the institutional lower limit of normal
• Ability to take oral medication and be willing to adhere to the pre-radiation temozolomide regimen
• For females of reproductive potential: use of highly effective contraception for at least 1 week prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of pr-radiation temozolomide administration
• For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
• Patients must have measurable disease as defined by RANO criteria.

You cannot join if

• Patients receiving any other investigational agents are ineligible.
• Patients who had Gliadel wafer or other local therapy placed in the tumor cavity during the tumor resection.
• Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to TMZ are ineligible.
• Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible.
• Pregnant women are excluded from this study because TMZ has potential for teratogenic or abortifacients effects. Breastfeeding should be discontinued if the mother is treated with TMZ.

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

• Pre-radiation temozolomide. (Drug): Patients will receive 2 cycles of pre-radiation temozolomide (200mg/m^2). Cycles are 28-days in length. Participants will take temozolomide on days 1-5 of the 28-day cycle.

Na · Single Group · masking: None

Main goals

• Response Rate (Post-operative MRI (day 0) until radiation simulation MRI (day 70).)

Other goals

• Secondary Outcome

Planned enrollment: 70 (estimated).

• Cooper University HealthCare, Camden, New Jersey

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

• ClinicalTrials.gov NCT07439172
• NCI Drug Dictionary: C1244

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 8, 2026. Public record; not medical advice.