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DHFR Inhibitor
Pyrimethamine for Head and Neck Cancer
Phase < 1
Recruiting
Led By Paul Zolkind, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of treatment through day 43 (estimated to be 6 weeks)
Awards & highlights
Study Summary
This trial will evaluate the antitumor activity of pyrimethamine on human tumors, specifically its effects on DHFR and NRF2 pathway activity.
Who is the study for?
Adults with HPV-negative, locally advanced head and neck squamous cell carcinoma (HNSCC) who are fit for surgery can join. They must have good organ function, be able to swallow pills, and agree to use contraception. Excluded are those with recent anticoagulant use, allergies to similar drugs, active alcohol abuse, uncontrolled illnesses like heart disease or infections, certain blood disorders or other cancers treated within the last 2 years.Check my eligibility
What is being tested?
The trial is testing Pyrimethamine's effect on tumors by inhibiting a protein called DHFR and reducing NRF2 activity which could help in treating cancer. The goal is to see if it increases DHFR levels in tumor cells by 50% and cuts down NRF2 activity by half in tumors that were already active before treatment.See study design
What are the potential side effects?
Pyrimethamine may cause side effects such as allergic reactions for those sensitive to its components. Since it affects folate metabolism, there might be risks of blood disorders like megaloblastic anemia due to folate deficiency.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of treatment through day 43 (estimated to be 6 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment through day 43 (estimated to be 6 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Log2 of tumor DHFR expression as measured by western blot analysis
Secondary outcome measures
Change in Log2 of NRF2 activity score as measured using the NRF2 SureQuant proteomic assay
Number of grade 3 or higher adverse events due to pyrimethamine
Number of participants with a delay in surgery by ≥ 10 days due to pyrimethamine
+1 moreSide effects data
From 2016 Phase 1 & 2 trial • 32 Patients • NCT0108366744%
Nausea
41%
Headache
19%
Diarrhea
16%
Pain
13%
Upper respiratory infection
9%
weight loss
6%
decreased appetite
3%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pyrimethamine
Trial Design
1Treatment groups
Experimental Treatment
Group I: PyrimethamineExperimental Treatment1 Intervention
Pyrimethamine will be taken by mouth at a dose of 50 mg once daily for 14 days (+/-2 days) with the last dose the day prior to surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pyrimethamine
2017
Completed Phase 2
~420
Find a Location
Who is running the clinical trial?
Tilde SciencesUNKNOWN
Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,675 Total Patients Enrolled
Vyera PharmaceuticalsUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am fully active and can carry on all my pre-disease activities without restriction.I have been on blood thinners within a year before my head or neck cancer diagnosis.I have taken pyrimethamine within a year before my head and neck cancer diagnosis.I had cancer before, but I finished treatment over 2 years ago and am now cancer-free.I agree to use birth control or abstain from sex during the study.I am currently taking phenytoin.My cancer is advanced head and neck cancer, not related to HPV, and I'm getting surgery to try to cure it.I have anemia caused by not having enough folate.I do not have any uncontrolled illnesses or infections, and I am not on immunosuppressive medications.I can have a biopsy for research before treatment or I already have a stored biopsy.I have received treatment for my cancer before.My blood tests and organ functions are within normal ranges, and I can swallow pills.I have HIV but my CD4+ T-cell count is above 350 and I haven't had an AIDS-related infection in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Pyrimethamine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available for participants in this trial?
"According to clinicaltrials.gov, this research project is no longer accepting participants after its initial posting on April 30th 2023 and last edit on January 4th of the same year. Despite that, there are still 2,929 other trials looking for enrollees as we speak."
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