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Not yet recruiting NCT07439172

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

Phase II Interventional High Grade Gliomas Glioblastoma Astrocytoma Oligodendroglioma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pre-radiation temozolomide..
Who it may be relevant to
Registry conditions: High Grade Gliomas, Glioblastoma, Astrocytoma, Oligodendroglioma. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multi-Centered Evaluation of Pre-Radiation Chemotherapy for Newly Diagnosed High-Grade Glioma (HGG): An Approach to Drug Screening That Requires Confirmation

Overview

Better treatments are needed for high-grade gliomas (HGG), and new ways of treating this disease should be tested. The investigators want to see if giving medicine before radiation works well. After radiation, MRI scans can be harder to understand because radiation changes how the brain looks on the scan. If new medicines are given before radiation, the scans are easier to read. First, the investigators need to find out if giving chemotherapy early works using a drug we already know can treat gliomas. The investigators will start with temozolomide, which is the only chemotherapy approved by the FDA for HGG. If this approach is successful, the investigators can then test new drugs using this screening method.

Interventions

  • Drug Pre-radiation temozolomide.
    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.

Primary outcome measures

  • Response Rate [Time frame: Post-operative MRI (day 0) until radiation simulation MRI (day 70).]
Secondary outcome measures (1)
  • Secondary Outcome [Time frame: From start of pre-radiation chemotherapy (day 10) until 2 cycles of pre-radiation temozolomide are complete (day 70)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07439172 · 25-242

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗