MPS Therapy for Sarcoma
(HopES Trial)

Recruiting in Palo Alto (17 mi)

Sant Chawla MD - SARC Clinical Trialist ...

Overseen bySant P Chawla, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sarcoma Oncology Research Center, LLC

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The primary objective is to evaluate the efficacy of SM-88, a combination metabolic cancer treatment, in two study cohorts: * Clinically advanced Ewing's Sarcoma patients who have not progressed at the conclusion of systemic treatment * Clinically advanced sarcoma patients in the salvage treatment setting Up to 24 efficacy evaluable patients (up to 12 per cohort) will be enrolled. Study patients will receive oral SM-88, with scheduled safety and efficacy evaluations.

Research Team

Sant P Chawla, MD

Principal Investigator

Sarcoma Oncology Research Center

Eligibility Criteria

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.

Inclusion Criteria

Radiographic disease assessment within 35 days prior to enrollment and planned treatment start with study drug

Adequate organ function defined as all laboratory parameters ≤ Grade 2 NCI CTCAE criteria

1-3 prior lines of systemic treatment (including current treatment) for maintenance treatment cohort

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Exclusion Criteria

Evidence of viral infections including human immunodeficiency virus (HIV), hepatitis B, and hepatitis C

Major surgery within 30 days

Current or anticipated treatment with a contraindicated medication

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Treatment Details

Interventions

SM-88 (Combination Metabolic Cancer Treatment)

Trial OverviewThe 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.

Participant Groups

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