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Compensation: Varies

Number of Visits: 29

Duration: Up to 48 weeks

31 Participants Needed

MPS Therapy for Sarcoma
(HopES Trial)

Sant Chawla MD - SARC Clinical Trialist ...

Overseen BySant P Chawla, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Sarcoma Oncology Research Center, LLC

Must not be taking: Systemic anticancer agents

Disqualifiers: Major surgery, Viral infections, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

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.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking any systemic anticancer agents at least 14 days before starting the study treatment. If you are on other medications, the protocol does not specify, but you should discuss this with the study team.

Is MPS Therapy (SM-88) safe for humans?

The research articles provided do not contain specific safety data for MPS Therapy (SM-88) in humans.¹ ² ³ ⁴ ⁵

How does MPS Therapy for Sarcoma differ from other treatments?

MPS Therapy for Sarcoma is unique because it involves a combination treatment strategy that targets the cell cycle, specifically using CDK4/6 inhibitors like palbociclib to arrest Rb-positive sarcoma cells in the G1 phase, making them more sensitive to other drugs like Wee1 kinase inhibitors. This approach is different from traditional treatments like surgery, radiation, and chemotherapy, and offers a novel way to potentially improve outcomes for patients with sarcomas.⁶ ⁷ ⁸ ⁹ ¹⁰

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

See 8 more

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

See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily oral treatment with SM-88 in continuous 28-day cycles

Up to 48 weeks

Visits every 28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Long-term Follow-up

Participants are monitored for overall survival and clinical benefit rate

Every 3 months for up to 2 years

Treatment Details

Interventions

SM-88

Trial Overview 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.

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sarcoma Oncology Research Center, LLC

Lead Sponsor

Trials

Recruited

910+

Joseph Ahmed Foundation

Collaborator

Trials

Recruited

30+

Tyme, Inc

Industry Sponsor

Trials

Recruited

200+

Findings from Research

Ecteinascidin-743 (ET-743) demonstrated antitumoral activity in advanced soft tissue sarcoma patients, with a 4% overall response rate and a 24% disease progression control rate at 6 months, indicating some effectiveness in a challenging patient population.

The treatment had a manageable safety profile, although 50% of patients experienced significant liver enzyme elevations and 61% had severe neutropenia, with two treatment-related deaths occurring due to complications likely linked to protocol violations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of ecteinascidin-743 in advanced pretreated soft tissue sarcoma patients.Yovine, A., Riofrio, M., Blay, JY., et al.[2018]

MK1775, a Wee1 inhibitor, shows promising therapeutic efficacy in treating sarcomas by inducing apoptotic cell death and enhancing the effects of gemcitabine, a commonly used chemotherapy drug, in various sarcoma cell lines and patient-derived samples.

The study demonstrated that MK1775 has a high safety profile and effectively induces significant cell death in a mouse model of osteosarcoma, suggesting its potential as a new treatment option for both adult and pediatric sarcoma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wee1 inhibition by MK-1775 leads to tumor inhibition and enhances efficacy of gemcitabine in human sarcomas.Kreahling, JM., Foroutan, P., Reed, D., et al.[2022]

A new combination treatment strategy using the CDK4/6 inhibitor palbociclib shows promise for treating Rb-positive soft tissue sarcomas by inducing cell cycle arrest, making the cancer cells more sensitive to other treatments like doxorubicin.

This synergistic effect was confirmed in both laboratory tests and in vivo studies using patient-derived xenografts, providing strong preclinical support for future clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CDK4/6 Inhibitors Sensitize Rb-positive Sarcoma Cells to Wee1 Kinase Inhibition through Reversible Cell-Cycle Arrest.Francis, AM., Alexander, A., Liu, Y., et al.[2022]