Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM

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 lo

Trial Details

NCT ID
NCT03213002
Phase
PHASE1 / PHASE2
Sponsor
Northwell Health
Status
RECRUITING
Cancer Type
Glioblastoma (GBM) Brain Cancer
Interventions
  • Capecitabine
  • Temozolomide
Locations (sample)
  • New York, New York, United States|40.71427,-74.00597

Key Eligibility Criteria

  • 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

For full eligibility, visit ClinicalTrials.gov.

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