Pemetrexed for the Treatment of Chordoma

  • STATUS
    Not Recruiting
  • End date
    May 31, 2023
  • participants needed
    15
  • sponsor
    John Wayne Cancer Institute
Updated on 19 August 2022

Summary

The purpose of this study is to test the safety and tolerability of pemetrexed administered to people with chordoma. Other purposes of this study are to:

  • find out side effects (good and bad) of pemetrexed;
  • learn more about how pemetrexed might affect the growth of cancer cells;
  • evaluate tumor characteristics by collecting tumor tissue samples if available;
  • look at biomarkers (biochemical features that can be used to measure the progress of disease or the effects of a drug) in blood and cerebrospinal fluid if available.

Description

This is a prospective, open-label, single-arm pilot feasibility study of pemetrexed for the treatment of adult patients with chordoma. All patients providing informed consent will be screened for eligibility. Eligible patients will receive pemetrexed by intravenous infusion on Day 1 of each 21-day treatment cycle, pre-medications (folic acid, vitamin B12, and dexamethasone), and ibuprofen if needed. Patients will continue dosing of pemetrexed until disease progression, unacceptable toxicity, withdrawal of consent, or treating physician determines it is in their best interest to stop. All patients will have regular evaluations for assessment of safety parameters and anti-tumor activity as detailed in the study flow chart.

Details
Condition Germ cell tumor, Germ Cell Tumors, Chordoma, Chordoma, Germ Cell Tumors
Treatment Pemetrexed
Clinical Study IdentifierNCT03955042
SponsorJohn Wayne Cancer Institute
Last Modified on19 August 2022

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