Actively Recruiting
Phase I/II Study of Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed Glioblastoma (GBM)
Led by Northwell Health · Updated on 2026-06-01
67
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining the oral chemotherapy drugs capecitabine and temozolomide to treat adults newly diagnosed with glioblastoma multiforme (GBM), a serious brain cancer. The study aims to see if adding capecitabine to the standard treatment with temozolomide after radiation can help patients respond longer and better to therapy. This trial is conducted in phases 1 and 2 to explore dosing and effects in this patient group. Participants will take capecitabine at a dose of 1500 mg/m2 divided into two daily doses for the first 14 days of each 28-day cycle. Temozolomide will be given at 150 mg/m2 to 200 mg/m2 divided into two doses from days 10 to 14, followed by 14 days off. This dosing schedule is designed to follow the initial six weeks of radiation and concurrent temozolomide treatment known as the Stupp protocol. The study focuses on the maintenance phase of treatment after radiation. Participants will be closely monitored through medical exams, lab tests, and imaging scans to measure progression-free survival at six months and overall survival up to four years. Side effects will be recorded and graded. Researchers will also assess overall response rates using standard criteria. The study duration may last several years, with ongoing safety checks and quality-of-life assessments to understand how well the treatment works and its impact on patients.
CONDITIONS
Brief Title
Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give informed consent
- Diagnosed with newly diagnosed Glioblastoma Multiforme WHO IV
- Completed 6 weeks of standard chemo-radiation (Stupp protocol) and not started maintenance temozolomide
- Agree to use effective contraception if of childbearing potential during treatment and for 2 months after
- Life expectancy greater than 3 months
- Aged between 18 and 74 years
- Performance status KPS 70 or greater
- Able to swallow pills and capsules
- Able to tolerate oral chemotherapy without serious allergies or side effects
- Adequate bone marrow, liver, and kidney function before starting therapy
You will not qualify if you...
- Prior chemotherapy with capecitabine or temozolomide for other cancers
- Prior chemotherapy for newly diagnosed GBM or Anaplastic Astrocytoma, except temozolomide during radiation
- History of severe allergic reactions to capecitabine, 5-FU, or temozolomide
- Serious medical or psychiatric illness preventing consent or treatment
- Prior malignancies within 5 years except treated carcinoma in-situ cancer free for 1 year
- Performance status KPS less than 70
- Unable to swallow pills or capsules
- Concurrent chemotherapy or active treatment including devices or high dose supplements
- Taking medications like Coumadin or phenytoin that interact with capecitabine
- History of coronary artery disease without cardiology evaluation
- Renal or liver insufficiency
- Blood clotting disorders
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles for at least 6 months
Participants receive oral Capecitabine and Temozolomide chemotherapy following completion of standard chemo-radiation therapy.
1 visit every 28 days during treatment cycles
Duration - Up to 4 years
Participants are monitored for progression-free survival and overall survival after treatment ends.
Periodic visits for evaluation up to 4 years
Trial Site Locations
Total: 1 location
1
Lenox Hill Brain Tumor Center
New York, New York, United States, 10075
Actively Recruiting
Research Team
J
John Boockvar, MD
T
Tamika Wong, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here