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Anti-metabolites

High-Dose Methotrexate for Breast Cancer

Phase 2

Recruiting

Led By Roy Strowd, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Group (ECOG) Performance Scale 0-1

Histologically or cytologically confirmed invasive breast cancer of the following subtype: TRIPLE NEGATIVE, HER2-POSITIVE, HORMONE REFRACTORY

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing the use of high-dose methotrexate to treat leptomeningeal disease (LMD) in patients with metastatic breast cancer. LMD is a cancer that has spread to the thin layer of tissue that covers the brain and spinal cord. There is no cure for LMD, and it is a difficult disease to treat because it is hard to reach with traditional cancer treatments. HD-MTX is a chemotherapy drug that has been shown to be effective against breast cancer, and it is hoped that it will be effective against LMD as well. This study is being done to see if HD-MTX is

Who is the study for?

This trial is for adults over 18 with invasive breast cancer that's triple negative, HER2-positive, or hormone refractory. They must have leptomeningeal metastasis confirmed by tests and be in good physical condition (ECOG 0-1). People can't join if they've had certain treatments recently, are pregnant/breastfeeding, have severe heart failure or fluid collections like ascites, adverse reactions to methotrexate before, uncontrolled diseases, or are on conflicting medications.Check my eligibility

What is being tested?

The study is testing high-dose Methotrexate (HD-MTX) given intravenously to see if it helps patients with breast cancer who also have leptomeningeal metastasis. It's a phase II trial aiming to provide prospective data since current use of HD-MTX lacks strong evidence but is suggested by retrospective studies and included in NCCN Guidelines due to limited treatment options.See study design

What are the potential side effects?

High-dose Methotrexate may cause side effects such as mouth sores (mucositis), delayed drug clearance leading to increased toxicity especially in patients with significant fluid collections like ascites. Other potential side effects include blood disorders, liver toxicity, kidney problems and lung inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My breast cancer is triple negative, HER2-positive, or hormone refractory.

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My cancer has spread to the lining of my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Survival (at 12 weeks)

Secondary outcome measures

Cost

One year survival

Percentage of Cytologic Sterilization

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: High-dose Methotrexate (8 gm/m2; HD-MTX)Experimental Treatment1 Intervention

Enrolled patients will undergo treatment with HD-MTX (8 g/m2) as per current standard practice on an every 2 week schedule until disease progression or death from any cause. Treatment will be performed according to standard clinical practice. Surveillance imaging with or without cytologic evaluation will be performed as per standard clinical practice after every 2 cycles (~28 days). Treatment will continue until there is unequivocal evidence of clinical or radiographic CNS or systemic disease progression, death from any cause, or intolerance.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,241 Previous Clinical Trials

1,004,221 Total Patients Enrolled

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsOTHER

557 Previous Clinical Trials

32,884 Total Patients Enrolled

Roy Strowd, MDPrincipal InvestigatorWake Forest University Health Sciences

6 Previous Clinical Trials

118 Total Patients Enrolled

Media Library

High-dose Methotrexate (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02422641 — Phase 2

Leptomeningeal Disease Research Study Groups: High-dose Methotrexate (8 gm/m2; HD-MTX)

Leptomeningeal Disease Clinical Trial 2023: High-dose Methotrexate Highlights & Side Effects. Trial Name: NCT02422641 — Phase 2

High-dose Methotrexate (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02422641 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently accepted for this clinical research?

"Affirmative. The clinical trial website reveals that this study is actively recruiting patients for its research - it was initially posted on the 1st of May 2015 and recently edited on the 3rd of October 2020. 16 people are needed from three different sites to participate in this investigation."

Answered by AI

In what illnesses does High-dose Methotrexate (8 gm/m2; HD-MTX) typically provide relief?

"High-dose Methotrexate (HD-MTX) is a commonly prescribed therapy for small cell lung cancer. It has also proven to be effective in the treatment of active pauciarticular juvenile rheumatoid arthritis, head and neck carcinoma, multiple sclerosis."

Answered by AI

What empirical evidence has been gathered on the safety and efficacy of 8 gm/m2 High-dose Methotrexate (HD-MTX)?

"Currently, there are 219 trials studying High-dose Methotrexate (8 gm/m2; HD-MTX), of which 67 have entered Phase 3. While most research initiatives for this treatment occur in New york City, 7698 sites nationwide are conducting clinical studies on the subject matter."

Answered by AI

Does the Food & Drug Administration recognize High-dose Methotrexate (8 gm/m2; HD-MTX) as a legitimate treatment?

"The safety score for HD-MTX was 2 since there is existent data that shows its safety, however efficacy has not been proven."

Answered by AI

Are there still vacancies in this experiment for participants?

"Data on clinicaltrials.gov verifies that this research project is presently looking for individuals to enroll in the trial, which was initially posted on May 1st 2015 and recently updated October 3rd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis

2015. "Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02422641.

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