High Grade Gliomas study: Pre-radiation temozolomide.
Official title Pre-Radiation Chemotherapy for Newly Diagnosed High-Grade Glioma.
ClinicalTrials.gov ID: NCT07439172
What this study is testing
What is Pre-radiation temozolomide?
This is an investigational chemotherapy medicine being studied as a potential treatment for high-grade gliomas. It is designed to stop cancer cells from making copies of their DNA, which prevents them from growing and dividing.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study checks if giving chemotherapy before radiation is a good way to treat high-grade gliomas. It also aims to make brain scans easier to read after treatment.
- Who it's for
- People who have just been diagnosed with high-grade gliomas, such as glioblastoma or astrocytoma.
- What's involved
- Participants will receive temozolomide, a known chemotherapy drug, before starting radiation therapy.
- Time commitment
- The source text does not specify the total duration or number of visits.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
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
You likely can't 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...
- Pregnant women are excluded from this study because TMZ has potential for teratogenic or abortifacients effects.
See the full eligibility 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...
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Camden, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Camden, New Jersey, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.