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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03955042
Study type Interventional
Source Saint John's Cancer Institute
Contact
Status Completed
Phase Phase 1
Start date September 6, 2019
Completion date January 18, 2023

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