ChordomaPhase 1NCT03955042
Pemetrexed for the Treatment of Chordoma
A Phase 1 study testing Pemetrexed in people with Chordoma, run by Saint John's Cancer Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chordoma
- What is being tested?
- Pemetrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2019to 18 Jan 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
John Wayne Cancer Institute
Santa Monica, California, 90404
About this study
Official title: Pilot Study of Pemetrexed for the Treatment of Chordoma
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.
Read the detailed description
This is a prospective, open-label, single-arm pilot feasibility study of pemetrexed for the treatment of adult patients with chordoma. All patients providing informed consent will be screened for eligibility. Eligible patients will receive pemetrexed by intravenous infusion on Day 1 of each 21-day treatment cycle, pre-medications (folic acid, vitamin B12, and dexamethasone), and ibuprofen if needed. Patients will continue dosing of pemetrexed until disease progression, unacceptable toxicity, withdrawal of consent, or treating physician determines it is in their best interest to stop. All patients will have regular evaluations for assessment of safety parameters and anti-tumor activity as detailed in the study flow chart.
- Conditions
- Chordoma
- Being tested
- Pemetrexed
- Medical subject headings
- Chordoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemetrexedDrug
Also called Alimta
Pemetrexed 900 mg/m^2 on Day 1 of each 21-day cycle. Supportive medications of ibuprofen, folic acid, vitamin B12, and dexamethasone.
| Study group | Role | What they receive |
|---|---|---|
| Pemetrexed | Experimental | Pemetrexed Receives: Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
duration of time from start of treatment until objective tumor progression or withdrawal
Measured: one year
Radiographic response assessed by RECIST v1.1
rate of radiographic imaging alterations following treatment
Measured: one year
Secondary outcomes (1)
Toxicity assessed by CTCAE v 4.03 criteria
proportion of patients experiencing adverse events
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start6 Sep 2019
- Primary completion27 Jul 2022
- Study completion18 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ChordomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint John's Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Chordoma Foundation
- Responsible party
- Principal investigator, Santosh Kesari, Saint John's Cancer Institute
- Investigators
- Santosh Kesari, MD, PhD, Principal investigator, Saint John's Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955042
- Sponsor's protocol ID
- JWCI-18-0704
- Other IDs
- H3E-US-X091
- Status last verified
- Mar 2023
- First submitted
- 14 May 2019
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 37147496
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Pemetrexed for the Treatment of Chordoma
- ClinicalTrials.gov ID
- NCT03955042
- Acronym / sponsor ID
- JWCI-18-0704
- Conditions
- Chordoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Saint John's Cancer InstituteUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, Chordoma Foundation
- Study start
- 6 Sep 2019 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 17 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, open-label, single-arm pilot feasibility study of pemetrexed for the treatment of adult patients with chordoma. All patients providing informed consent will be screened for eligibility. Eligible patients will receive pemetrexed by intravenous infusion on Day 1 of each 21-day treatment cycle, pre-medications (folic acid, vitamin B12, and dexamethasone), and ibuprofen if needed. Patients will continue dosing of pemetrexed until disease progression, unacceptable toxicity, withdrawal of consent, or treating physician determines it is in their best interest to stop. All patients will have regular evaluations for assessment of safety parameters and anti-tumor activity as detailed in the study flow chart.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pemetrexed | Experimental | Drug: PemetrexedPemetrexed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (23 listed)
- 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:
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PemetrexedAlso: AlimtaPemetrexed 900 mg/m^2 on Day 1 of each 21-day cycle. Supportive medications of ibuprofen, folic acid, vitamin B12, and dexamethasone. | Drug | Pemetrexed |
Primary outcome
Progression free survival
Time frame: one year
duration of time from start of treatment until objective tumor progression or withdrawal
Radiographic response assessed by RECIST v1.1
Time frame: one year
rate of radiographic imaging alterations following treatment
1 secondary outcome
Toxicity assessed by CTCAE v 4.03 criteria
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Derived from this study: PubMed 37147496Kesari 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santosh Kesari, MD, PhD principal investigator
Saint John's Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pemetrexed in people with Chordoma, run by Saint John's Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03955042, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.