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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
No Placebo-Only Group

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 weeks
Treatment ~ Varies
Follow Up ~every 3 months for up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 3 months for up to 2 years for reporting.

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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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

Find a Location

Who is running the clinical trial?

Joseph Ahmed FoundationUNKNOWN
Sarcoma Oncology Research Center, LLCLead Sponsor
8 Previous Clinical Trials
535 Total Patients Enrolled
Tyme, IncIndustry Sponsor
4 Previous Clinical Trials
164 Total Patients Enrolled

Media Library

Combination metyrosine-derivative, low-dose methoxsalen, phenytoin and sirolimus (MPS) Clinical Trial Eligibility Overview. Trial Name: NCT03778996 — Phase 2
Ewing's Tumor Research Study Groups: Maintenance Treatment: Ewing's Sarcoma, Salvage Treatment: Sarcoma
Ewing's Tumor Clinical Trial 2023: Combination metyrosine-derivative, low-dose methoxsalen, phenytoin and sirolimus (MPS) Highlights & Side Effects. Trial Name: NCT03778996 — Phase 2
Combination metyrosine-derivative, low-dose methoxsalen, phenytoin and sirolimus (MPS) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03778996 — Phase 2
~0 spots leftby Dec 2024
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