Combining capecitabine and temozolomide for newly diagnosed glioblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of administering capecitabine alongside temozolomide for patients with newly diagnosed glioblastoma multiforme (GBM). Participants will receive a dosage of 1500 mg/m2 of capecitabine after completing radiation therapy and starting their monthly regimen of temozolomide. The goal is to determine if this combination improves treatment response duration compared to temozolomide alone, which is the current standard of care. The trial aims to enhance survival rates and quality of life for patients suffering from this aggressive brain tumor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Be capable of giving informed consent.
2. Have a pathology proven diagnosis of any of newly diagnosed Glioblastoma Multiforme WHO IV
3. Have completed the first part of standard of care chemo-radiation (Stupp), for 6 weeks, and not started the maintenance phase of temozolomide
4. Agree to use effective barrier contraception while on treatment and for 2 months thereafter, if of childbearing potential
5. Have a life expectancy \> 3 months
6. Be between the ages of 18 to 74
7. Have a performance status KPS 70 or greater
8. Be able to swallow pills and capsules
9. Be able to tolerate oral chemotherapeutic medications, with no health threatening allergies or side effects, based on lab and clinical findings
10. Have adequate bone marrow function, liver function and renal function before commencing therapy

Exclusion Criteria:

1. Prior chemotherapy with capecitabine or temozolomide for other prior malignancies. Patients previously treated with continuous infusion 5-FU or any schedule of DTIC, which are similar to capecitabine and temozolomide, respectively, will be excluded.
2. Prior chemotherapies for newly diagnosed GBM or AA, other than temozolomide during radiation.
3. Patients with a history of severe hypersensitivity reaction to capecitabine, 5-FU, temozolomide (i.e. anaphylaxis or anaphylactic reactions),
4. Serious medical or psychiatric illness preventing informed consent or treatment (e.g., serious infection)
5. Prior malignancies in the last 5 years other than curatively treated carcinoma in-situ previously treated with curative intent (cancer free for the past one year).
6. Performance status, KPS \< 70
7. Inability to swallow pills and capsules
8. Concurrent chemotherapy or treatment for the active disease, including devices such as Optune, high dose vitamin supplements, or any other chemotherapy
9. Patients taking concomitant medications such as Coumadin and phenytoin medications, need to be excluded because of interactions with capecitabine
10. Patients with previously documented CAD will need to be evaluated by cardiology prior to start to help risk stratify for capecitabine tolerance
11. Patients with renal insufficiency or hepatic insufficiency
12. Patients with coagulopathies
13. Women who are pregnant or lactating.

Where it's running

• Lenox Hill Brain Tumor Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: John Boockvar, MD — Lenox Hill Hospital-Northwell Health
• Study coordinator: John Boockvar, MD
• Email: jboockvar@northwell.edu
• Phone: 212-434-3900

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.