Pemetrexed for the Treatment of Chordoma

Completed · Phase 1

Conditions studied: Chordoma

In brief

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.

Key facts

Study ID

NCT03955042

Run by

Saint John's Cancer Institute

People needed

15

Starts

2019-09-06

Expected to finish

2023-01-18

Last updated by the study team

2023-03-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant has the ability to understand and the willingness to provide a signed and dated informed consent form.
• Participant has the willingness to comply with all study procedures and availability for the duration of the study.
• Participant has a diagnosis of chordoma.
• Participant is male or female, 18 years of age or older.
• Participant has a Karnofsky Performance Status of 50% or greater.
• Participant has adequate organ function:
• ANC at least 1.5 x 10\^9/L or higher
• Platelets at least 100 x 10\^9/L or higher
• Hemoglobin at least 8 g/dL or higher.
• Total bilirubin 1.5 x upper limit of normal (ULN) or lower.
• ALT and AST 3 x ULN or lower.
• Serum creatinine 1.5 x ULN or lower.
• Participant has the ability to interrupt non-steroidal anti-inflammatory drugs (NSAIDS) 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of Pemetrexed.
• Participant has the ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.
• Participant has recovered from any previous therapy-related toxicity to CTCAE Grade 1 or to their clinical baseline at study entry.

You may not qualify if…

• Participant is less than 28 days from any investigational agent.
• Participant has third space fluid which cannot be controlled by drainage.
• Participant has a severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study intervention, including, but not limited to:
• Uncontrolled diabetes;
• Renal disease that requires dialysis;
• Pulmonary disorder requiring supplemental oxygen to keep saturation >95% and the situation is not expected to resolve within 2 weeks;
• Severe dyspnea at rest or requiring oxygen therapy;
• Interstitial lung disease;
• History of major surgical resection involving the stomach or small bowel;
• Preexisting Crohn's disease;
• Ulcerative colitis;
• Uncontrolled vasculitis and/or disease with known vasculitis;
• Preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea;
• Psychiatric illness/social situations that would limit compliance with study requirements.
• Participant has an active bacterial infection requiring intravenous [IV] antibiotics at time of initiating study treatment, fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C).
• Participant has a personal history or presence of any of the following cardiovascular conditions:
• Syncope of cardiovascular etiology;
• Ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation);
• Myocardial infraction within 6 months of investigational product administration;
• Unstable angina;
• Sudden cardiac arrest;
• Congestive heart failure (NYHA classification ≥ 3).
• Participant is a female of childbearing potential who is pregnant or nursing.

Where it is running

• John Wayne Cancer Institute — Santa Monica, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.