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MPS Therapy for Sarcoma (HopES Trial)
Phase 2
Waitlist Available
Led By Sant P Chawla, MD
Research Sponsored by Sarcoma Oncology Research Center, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 3 months for up to 2 years
Awards & highlights
Summary
This trial is testing a new cancer treatment on people who have either not responded to other treatments or have relapsed.
Who is the study for?
This trial is for people aged ≥12 with advanced Ewing's Sarcoma or other sarcomas, who've had up to three prior treatments. They must have stable disease after their latest treatment or a partial/full response without progression. Participants need good organ function and an ECOG performance status of 0-2, meaning they can care for themselves and are up and about more than half the day.
What is being tested?
The trial tests SM-88 (a mix of metyrosine-derivative, methoxsalen, phenytoin, sirolimus) in patients with advanced Ewing's Sarcoma post-treatment without disease progression and those needing salvage therapy for any sarcoma. Up to 24 patients will take oral SM-88 with regular safety checks and assessments of its effectiveness.
What are the potential side effects?
While specific side effects aren't listed here, participants may experience reactions related to the individual components of SM-88: skin sensitivity due to methoxsalen; nervous system effects from phenytoin; immune suppression by sirolimus; plus potential unknown risks from the new combination.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 3 months for up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 3 months for up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Response Rate
Therapeutic procedure
Stable Disease for at Least 3 Months
Secondary study objectives
Clinical Benefit Rate
Duration of Response
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Salvage Treatment: SarcomaExperimental Treatment1 Intervention
Combination metyrosine-derivative, low-dose methoxasalen, phenytoin and sirolimus
Group II: Maintenance Treatment: Ewing's SarcomaExperimental Treatment1 Intervention
Combination metyrosine-derivative, low-dose methoxsalen, phenytoin and sirolimus
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Who is running the clinical trial?
Joseph Ahmed FoundationUNKNOWN
Sarcoma Oncology Research Center, LLCLead Sponsor
8 Previous Clinical Trials
535 Total Patients Enrolled
7 Trials studying Sarcoma
455 Patients Enrolled for Sarcoma
Tyme, IncIndustry Sponsor
4 Previous Clinical Trials
166 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Maintenance Treatment: Ewing's Sarcoma
- Group 2: Salvage Treatment: Sarcoma
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.
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