Capecitabine with temozolomide for newly diagnosed glioblastoma

You may qualify if

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

You can't join if

• 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.
• Prior chemotherapies for newly diagnosed GBM or AA, other than temozolomide during radiation.
• Patients with a history of severe hypersensitivity reaction to capecitabine, 5-FU, temozolomide (i.e. anaphylaxis or anaphylactic reactions),
• Serious medical or psychiatric illness preventing informed consent or treatment (e.g., serious infection)
• 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).
• Performance status, KPS < 70
• Inability to swallow pills and capsules
• Concurrent chemotherapy or treatment for the active disease, including devices such as Optune, high dose vitamin supplements, or any other chemotherapy
• Patients taking concomitant medications such as Coumadin and phenytoin medications, need to be excluded because of interactions with capecitabine
• Patients with previously documented CAD will need to be evaluated by cardiology prior to start to help risk stratify for capecitabine tolerance
• Patients with renal insufficiency or hepatic insufficiency
• Patients with coagulopathies
• Women who are pregnant or lactating.