Capecitabine and Temozolomide for Newly Diagnosed GBM

Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM

Recruiting Phase 1 Phase 2 Interventional Study
Glioblastoma Multiforme (GBM) Glioblastoma Glioma of Brain Glioblastoma, Adult Brain Tumor Brain Tumor, Primary Brain Tumor Adult Cancer Brain Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 74
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
67 (estimated)
Sponsor
Northwell Health · Other
Who this trial is looking for

This trial is looking for adults who have been diagnosed with glioblastoma multiforme and have completed their initial treatment. Participants will take the medication capecitabine along with temozolomide to see if it improves treatment response.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have a confirmed diagnosis of glioblastoma multiforme.
  • I have completed 6 weeks of standard chemo-radiation.
  • I agree to use effective contraception if I can become pregnant.
  • I am 18 to 74 years old.
  • I have a performance status score of 70 or higher.
  • I can swallow pills and capsules.
  • I have adequate bone marrow, liver, and kidney function.
  • I expect to live more than 3 months.

You may not be able to join if

  • I have had chemotherapy with capecitabine or temozolomide before.
  • I have a history of severe allergic reaction to capecitabine or temozolomide.
  • I cannot swallow pills and capsules.
  • I have a serious illness that would prevent me from participating.
  • I have had another cancer in the last 5 years except for certain types.
  • My performance status score is below 70.
  • I am currently undergoing other chemotherapy for my disease.
  • I am pregnant or breastfeeding.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 o…
Trial Locations
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Eligibility Criteria
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 temozolomid…
Contacts

John Boockvar, MD

212-434-3900

jboockvar@northwell.edu

CONTACT

Tamika Wong, MPH

212-434-4836

twong4@northwell.edu

CONTACT