Pemetrexed for the treatment of chordoma
This is a Phase 1 trial studying the safety and initial effectiveness of a chemotherapy drug called pemetrexed (brand name Alimta) in treating chordoma. Pemetrexed is a folate antimetabolite that works by interfering with certain enzymes that are needed for the growth and survival of cells. The study is designed specifically for chordoma patients 18 years and older. It is currently open at John Wayne Cancer Institute. The principal investigator for this study is Dr. Santosh Kesari.
Why this trial is being done
Pemetrexed works by inhibiting a number of enzymes essential to the process of cells dividing and growing. It is currently FDA approved to treat pleural mesothelioma and non-small cell lung cancer.
Thymidylate synthase (TS) is one enzyme inhibited by pemetrexed. Recent studies have found that when the level of the TS enzyme is low within tumor cells, pemetrexed is more effective at stopping tumor growth, and in some cases shrinking tumors, than when the TS level is high.
In a sample of chordoma tumors, over 80% were found to be TS negative (or low) by immunohistochemistry (IHC) testing providing the rationale to study pemetrexed for its effectiveness in inhibiting chordoma tumors from growing.
This trial aims to provide evidence of pemetrexed’s ability to shrink or stop the growth of chordoma tumors. It will also seek to learn more about any side effects of pemetrexed and why certain patients may respond to this drug better than others.
Who can participate
This trial is designed specifically for chordoma patients over the age of 18 years old. Patients must meet the following criteria to be eligible:
- Confirmed diagnosis of chordoma
- Recurrent, non-operable, or When tumors have spread to other parts of the body from the original tumor site. confirmed by imaging
- Progression of disease documented in last 6 months
- More than 28 days since the use of any investigational drug
- Age 18 years or older
- No major laboratory abnormalities
- Willing and able to travel to the enrolling study site for all treatment and follow-up visits
Full eligibility criteria can be found at ClinicalTrials.gov.
How the trial will work
- Participants will receive an Any fluids given inside a vein. These could be treatment, medications, blood, or contrast dye for MRI and CT scans. infusion of 900 mg/m2 of pemetrexed every 3 weeks for 18 cycles or until there is tumor growth, severe side effects or change in health, or the participant leaves the trial.
- Ibuprofen, folic acid, vitamin B12, and dexamethasone will also be given on a regular schedule as supportive medications, to help lower the risk of side effects.
- Check-up exams will be performed every 3 weeks and imaging done every 6 weeks.
- All exams, treatments, and evaluations are provided at the trial site where the patient enrolled in the study. Participants not local to the trial site MUST be willing and able to travel to their trial site for all visits required by the trial.
How to enroll in this trial
The trial team will see all potential patients in a clinic visit before beginning the screening process. See the FAQ, “How do I find out if I’m eligible to participate?”, below for more specific information on enrolling.
If you have more questions about this trial or other clinical trials that may be options for chordoma patients, please contact a Chordoma Foundation Patient Navigator.
Medical information provided by the Chordoma Foundation in any medium is for informational and educational purposes only. After reading content from the Chordoma Foundation, review the information carefully with your physician. Information from the Chordoma Foundation is not a substitute for consultations with qualified health care professionals who are familiar with your medical conditions and needs. The Chordoma Foundation strongly recommends that care and treatment decisions be made in consultation with your physician or other qualified health care professionals who are familiar with your specific health situation.