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Combination metyrosine-derivative, low-dose methoxsalen, phenytoin and sirolimus (MPS) for Sarcoma (HopES Trial)
HopES Trial Summary
This trial is testing a new cancer treatment on people who have either not responded to other treatments or have relapsed.
- Sarcoma
- Ewing Sarcoma
HopES Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowHopES Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.HopES Trial Design
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Who is running the clinical trial?
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- You have a history of light-sensitive diseases that would make it unsafe for you to use methoxsalen.You have received any number of treatments before joining the study.You have received previous treatment with SM-88.You have taken any cancer medications in the two weeks before starting the study.You have had bad reactions or allergies to any of the ingredients in SM-88 before.You have a type of cancer called sarcoma, which is advanced and cannot be removed through surgery. There is no standard treatment available for your condition, and there are no other options for a cure.
- Group 1: Maintenance Treatment: Ewing's Sarcoma
- Group 2: Salvage Treatment: Sarcoma
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What does MPS stand for and what are doctors using it to treat?
"MPS, which is a combination of metyrosine-derivative, low-dose methoxsalen, phenytoin and sirolimus, can help patients with epilepticus, tonic-clonic disorders, convulsive disorders, and pheochromocytomas."
Are there other trials that have used this combination of drugs before?
"At the moment, a total of 136 studies are being conducted that involve Combination metyrosine-derivative, low-dose methoxsalen, phenytoin and sirolimus (MPS). Of these ongoing trials, 15 are in Phase 3. Many of the research facilities for this treatment are based Cincinnati, Ohio; however, there are 1092 locations running these experiments globally."
How many individuals are being considered for this research project?
"Indeed, the clinical trial is currently ongoing and has been since 1/3/2020 according to information on clinicaltrials.gov. The study will take place at a single site and enroll 24 patients in total."
Are researchers looking for more participants at this time?
"Yes, as the clinicaltrials.gov website reflects, this study is still recruiting participants. The trial was originally advertised on January 3rd 2020 and received its last update on May 4th 2022."
What is the MPS drug cocktail's official standing with the FDA?
"Given that this is a phase 2 trial, meaning that while there are data supporting safety, there are none for efficacy, Power rates the combination of Metyrosine-derivative, low-dose methoxsalen, phenytoin and sirolimus (MPS) as being safe to use."
What goals does this trial hope to achieve?
"The key metric that will be monitored every 3 months for 2 years is 'Stable Disease for at Least 3 Months'. Other important measures of success include the 'Clinical Benefit Rate', defined as CR+PR+SD, which will use RECIST 1.1 guidelines. Additionally, researchers will track the Overall Survival rate from date of enrollment to date of death and also document any Treatment-Emergent Adverse Events using CTCAE v5 definition: 'Adverse events will be assessed at each visit and at unscheduled visits as clinically indicated.'"
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