RecruitingPhase 1Phase 2NCT03213002

Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM

Phase I/II Study of Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed Glioblastoma (GBM)

Sponsor

Northwell Health

Enrollment

67 participants

Start Date

Jun 13, 2017

Study Type

INTERVENTIONAL

Conditions

Cancer Brain Tumor Brain Cancer Glioblastoma Multiforme (GBM)Glioblastoma Glioblastoma, Adult Glioma of Brain Brain Tumor Adult Brain Tumor, Primary

Summary

The purpose of this study is to evaluate the safety and efficacy of administering the medication capecitabine along with temozolomide when you start your monthly regimen of oral temozolomide for the treatment of your newly diagnosed glioblastoma multiforme (GBM). Capecitabine is an oral chemotherapy that is given to patients with other types of cancer. The study will evaluate whether the dosage of 1500 mg/m2 of capecitabine is tolerable after radiation, when taken along with temozolomide. It will also try to determine if the medication capecitabine helps patients respond to treatment for a longer period of time compared to just temozolomide alone, which is the standard of care.

Eligibility

Min Age: 18 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding an oral chemotherapy drug called capecitabine to standard temozolomide maintenance therapy improves outcomes for patients with newly diagnosed glioblastoma (an aggressive brain tumor). **You may be eligible if...** - You are between 18 and 74 years old - You have been diagnosed with glioblastoma (WHO Grade IV brain tumor), confirmed by pathology - You have already completed the initial 6-week phase of radiation combined with temozolomide (the standard first-line treatment) and have not yet started maintenance temozolomide - Your expected survival is more than 3 months - You are able to use effective contraception during treatment if applicable **You may NOT be eligible if...** - You are under 18 or over 74 - You have not completed the initial chemoradiation phase - You have serious health conditions that make this treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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