Pemetrexed
Pemetrexed for the treatment of chordoma
Summary
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 metastatic diseaseWhen 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 intravenousAny 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.
FAQs
What are the costs to participate in the trial?
The study treatment, pemetrexed, is provided at no cost to participants. Participants and their insurance provider are responsible for the cost of check-ups and imaging done within the study, as this is considered standard of care.
Any other medical care needed while on the trial will be the responsibility of the patient or the patient’s insurance. Trial participants from out of town are responsible for any travel or lodging expenses necessary to make the required clinic visits every 3 weeks. The trial site may partner with local hotels to provide discounted rates to out-of-town patients.
What are the downsides of participating in the trial?
Side effects from chemotherapies are possible. Talking with your doctor or the trial investigators is the best way to learn about the risks of this particular chemotherapyA type of systemic therapy that is designed to kill rapidly dividing cancer cells. and of participating in this trial.
How do I find out if I'm eligible to participate?
If you and your doctor decide that this trial might be right for you, the next step is to contact the trial team. Mini Gill, RN is the contact person and she can be reached at (310) 582-7437 or
jaya.gill@providence.org. The main clinic can be reached at (310) 829-8265 or
neuro.oncology@providence.org.
The team will let you know where to send your medical records and what you can expect as next steps. One of these steps will be the informed consentThe process during which patients are given complete information about a treatment or clinical trial, including possible risks and benefits, so they can decide whether to have the treatment or participate in the trial. For clinical trials, this includes patient rights, including the ability to withdraw consent and leave the trial at any time. process, during which the team will fully explain all aspects of the trial including any potential benefits and risks, and whether you are eligible.
How effective is pemetrexed?
It is not currently known how effective pemetrexed is for the treatment of chordoma. One goal of this study is to determine the initial effectiveness of pemetrexed for treating chordoma.
How is the treatment given?
Study participants are given a 900 mg/m2 intravenous (IVAny fluids given inside a vein. These could be treatment, medications, blood, or contrast dye for MRI and CT scans.) infusion of pemetrexed every 3 weeks. The supportive treatments of ibuprofen, folic acid, vitamin B12, and dexamethasone are given orally.
How long will I be in this study?
The treatment is given every 3 weeks for 18 cycles, which equals one year. You may continue receiving pemetrexed as long as your doctor believes it is helping you and you don’t experience unacceptable side effects. After you complete the study or stop the treatment, the study would like to follow you throughout your life, but you can stop participating in the study at any time and for any reason.
What check-ups are involved during the study?
Regular check-ups are done at the trial clinic every 3 weeks, and MRIA type of imaging scan that is used initially to help diagnose chordoma, as well as during follow up to check for recurrence or metastasis. is done every 6 weeks. More follow ups may be scheduled if your health status requires it.
I don’t live near the trial sites. Can I still participate in the trial?
All exams, treatments, and evaluations are provided at the trial site. Patients not local to the trial site MUST be willing and able to travel to their study site for all visits required by the study. Travel and lodging expenses are the responsibility of the patient.
You may also be able to receive pemetrexed outside of this trial if your doctor prescribes it off-labelThe practice of prescribing drug treatments that are not approved by government agencies to treat a particular disease. Doctors are allowed to prescribe drugs off-label if they believe it is in the best interest of the patient.; however, it is unlikely to be covered by insurance or healthcare systems.
If you are unable to participate in this trial, there may be other trials available to you. See our Clinical Trials Catalogue or contact a Chordoma Foundation Patient Navigator for more information.
What happens if I decide to leave the trial and stop taking the drug?
You always have the option to stop treatment on a clinical trialResearch studies involving human subjects that are done to test whether a treatment is safe, and how well it will work to treat a specific disease.. If you decide to stop treatment for any reason, the study investigators would like to stay in touch with you so they can monitor side effects and understand how well the treatment worked. Approximately every 3‐6 months you will be asked, either by telephone or at an office visit, about your disease status and any cancer therapies you have had.
What happens if my tumor grows while enrolled in the study?
If your tumor grows while you are enrolled in the study but you are receiving clinical benefit (e.g., symptoms are reduced), the trial doctor will decide whether you can remain in the study. If your tumor grows and you are not experiencing any clinical benefit, the trial doctor will discuss other treatment options with you but you will no longer be able to participate in the study.
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.
Contact a 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.
