Pemetrexed for the Treatment of Chordoma

NCT03955042 | Completed Phase 1 FDA Drug

• 2 other identifiers: JWCI-18-0704H3E-US-X091
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chordoma

Outcome Measures

Primary Outcomes (2)

• Progression free survival

  duration of time from start of treatment until objective tumor progression or withdrawal

  one year

• Radiographic response assessed by RECIST v1.1

  rate of radiographic imaging alterations following treatment

  one year

Secondary Outcomes (1)

• Toxicity assessed by CTCAE v 4.03 criteria

  one year

Study Arms (1)

Pemetrexed

EXPERIMENTAL

Pemetrexed

Drug: Pemetrexed

Interventions

Pemetrexed DRUG

Pemetrexed 900 mg/m\^2 on Day 1 of each 21-day cycle. Supportive medications of ibuprofen, folic acid, vitamin B12, and dexamethasone.

Also known as: Alimta

Pemetrexed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Saint John's Cancer Institute: lead
• Eli Lilly and Company: collaborator
• Chordoma Foundation: collaborator

Study Sites (1)

John Wayne Cancer Institute

Santa Monica, California, 90404, United States

Location

Related Publications (1)

• Kesari S, Wang F, Juarez T, Ashili S, Patro CPK, Carrillo J, Nguyen M, Truong J, Levy J, Sommer J, Freed DM, Xiu J, Takasumi Y, Bouffet E, Gill JM. Activity of pemetrexed in pre-clinical chordoma models and humans. Sci Rep. 2023 May 5;13(1):7317. doi: 10.1038/s41598-023-34404-4.

  PMID: 37147496 DERIVED

MeSH Terms

Conditions

Chordoma

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Santosh Kesari, MD, PhD

  Saint John's Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Neuro-Oncology

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 17, 2019
• Study Start: September 6, 2019
• Primary Completion: July 27, 2022
• Study Completion: January 18, 2023
• Last Updated: March 7, 2023

Record last verified: 2023-03

Locations

US (1)