Actively Recruiting
Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM
Led by Northwell Health · Updated on 2025-04-09
67
Participants Needed
1
Research Sites
520 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be capable of giving informed consent
- Have a pathology proven diagnosis of newly diagnosed Glioblastoma Multiforme WHO IV
- Have completed 6 weeks of chemo-radiation (Stupp protocol) and not started maintenance temozolomide
- Agree to use effective barrier contraception during treatment and for 2 months after if of childbearing potential
- Have a life expectancy greater than 3 months
- Be between 18 and 74 years old
- Have a Karnofsky Performance Status (KPS) of 70 or greater
- Be able to swallow pills and capsules
- Be able to tolerate oral chemotherapy with no severe allergies or side effects
- Have 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 other than temozolomide during radiation
- History of severe hypersensitivity reactions to capecitabine, 5-FU, or temozolomide
- Serious medical or psychiatric illness preventing consent or treatment
- Previous malignancies within 5 years except curatively treated carcinoma in-situ cancer free for 1 year
- Karnofsky Performance Status less than 70
- Inability to swallow pills or capsules
- Concurrent chemotherapy or active treatments including devices like Optune or high-dose vitamins
- Use of medications like Coumadin or phenytoin that interact with capecitabine
- Known coronary artery disease needing cardiology evaluation before starting
- Renal or hepatic insufficiency
- Blood clotting disorders
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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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
CONTACT
T
Tamika Wong, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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