Phase 2 Brain Cancer Trial, Recruiting NCT03213002 Sponsor: Northwell Health Condition: Brain Cancer
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Phase 2 Brain Cancer Trial, Recruiting

NCT03213002
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are able to understand and agree to participate by giving informed consent
  • People who have been confirmed by pathology testing to have a newly diagnosed Grade IV Glioblastoma Multiforme (a type of brain tumour)
  • People who have finished the first 6-week phase of the standard combined chemotherapy and radiation treatment (known as the Stupp protocol) and have not yet started the follow-on maintenance phase
  • People who are willing to use effective barrier contraception during treatment and for 2 months after, if there is any possibility of becoming pregnant
  • People with a life expectancy of more than 3 months
  • People aged between 18 and 74 years
  • People with a functional ability score (KPS) of 70 or higher, meaning they are reasonably able to care for themselves (confirm with trial site)
  • People who are able to swallow pills and capsules
  • People who are able to tolerate oral chemotherapy medications, with no serious allergies or side effects, based on blood tests and clinical assessment
  • People whose bone marrow, liver, and kidney function are all within acceptable levels before starting treatment

Who may not be able to join:

  • People who have previously received chemotherapy with capecitabine or temozolomide for a different cancer, or who have received similar drugs (continuous infusion 5-FU or DTIC) for any prior malignancy
  • People who have received chemotherapy for their current brain tumour diagnosis, other than temozolomide given alongside radiation
  • People who have had a severe allergic reaction (such as anaphylaxis) to capecitabine, 5-FU, or temozolomide
  • People with a serious medical or psychiatric condition that would prevent them from giving informed consent or receiving treatment (for example, a serious active infection)
  • People who have had another cancer in the past 5 years, unless it was fully treated with the intent to cure and the person has been cancer-free for at least one year
  • People with a functional ability score (KPS) below 70
  • People who are unable to swallow pills and capsules
  • People currently receiving any other chemotherapy, active disease treatment, or using devices such as Optune, high-dose vitamin supplements, or any other chemotherapy at the same time
  • People taking certain medications such as Coumadin (warfarin) or phenytoin, which can interact with capecitabine
  • People with a previously documented history of coronary artery disease (a heart condition) would need to be assessed by a heart specialist before joining, to evaluate their suitability for capecitabine (confirm with trial site)
  • People with reduced kidney or liver function
  • People with blood clotting disorders
  • People who are pregnant or breastfeeding

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: John Boockvar, MD, Lenox Hill Hospital-Northwell Health

Phone: 212-434-3900

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Northwell Health
Registry
ClinicalTrials.gov
Start date
13 June 2017
Est. completion
1 June 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Progression-free survival (PFS); Overall Survival (OS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov