Pemetrexed for the Treatment of Chordoma

• Status: Recruiting
• Trial end date: 2023-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: John Wayne Cancer Institute
• Collaborators: Chordoma Foundation; Eli Lilly and Company
• Treatments: Pemetrexed

Criteria

Inclusion Criteria:

1. Participant has the ability to understand and the willingness to provide a signed and dated informed consent form.

2. Participant has the willingness to comply with all study procedures and availability for the duration of the study.

3. Participant has a diagnosis of chordoma.

4. Participant is male or female, 18 years of age or older.

5. Participant has a Karnofsky Performance Status of 50% or greater.

6. Participant has adequate organ function:

1. ANC at least 1.5 x 10^9/L or higher

2. Platelets at least 100 x 10^9/L or higher

3. Hemoglobin at least 8 g/dL or higher.

4. Total bilirubin 1.5 x upper limit of normal (ULN) or lower.

5. ALT and AST 3 x ULN or lower.

6. Serum creatinine 1.5 x ULN or lower.

7. 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.

8. Participant has the ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.

9. Participant has recovered from any previous therapy-related toxicity to CTCAE Grade 1 or to their clinical baseline at study entry.

Exclusion Criteria:

1. Participant is less than 28 days from any investigational agent.

2. Participant has third space fluid which cannot be controlled by drainage.

3. 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:

1. Uncontrolled diabetes;

2. Renal disease that requires dialysis;

3. Pulmonary disorder requiring supplemental oxygen to keep saturation >95% and the situation is not expected to resolve within 2 weeks;

4. Severe dyspnea at rest or requiring oxygen therapy;

5. Interstitial lung disease;

6. History of major surgical resection involving the stomach or small bowel;

7. Preexisting Crohn's disease;

8. Ulcerative colitis;

9. Uncontrolled vasculitis and/or disease with known vasculitis;

10. Preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea;

11. Psychiatric illness/social situations that would limit compliance with study requirements.

4. 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).

5. Participant has a personal history or presence of any of the following cardiovascular conditions:

1. Syncope of cardiovascular etiology;

2. Ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation);

3. Myocardial infraction within 6 months of investigational product administration;

4. Unstable angina;

5. Sudden cardiac arrest;

6. Congestive heart failure (NYHA classification ≥ 3).

6. Participant is a female of childbearing potential who is pregnant or nursing.