What side effects are associated with this type of intervention?

Common treatments for Ewing Sarcoma include chemotherapy agents such as topotecan and cyclophosphamide, which are also being studied in combination with Seclidemstat. The side effects of these treatments can include nausea, vomiting, diarrhea, fatigue, decreased appetite, and myelosuppression (reduced bone marrow activity leading to fewer blood cells). Serious adverse events may include cardiac toxicity and renal failure. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The context does not provide specific information on prior FDA approvals for the treatment of Ewing Sarcoma, particularly those similar to Seclidemstat (an LSD1 inhibitor). Generally, treatment for Ewing Sarcoma has included chemotherapy agents such as topotecan and cyclophosphamide, which are being studied in combination with Seclidemstat in current trials. Other treatments have involved multi-agent chemotherapy regimens, surgery, and radiation therapy.

What other types of research exist?

Promising novel alternatives to Seclidemstat for Ewing Sarcoma patients include the combination of topotecan and cyclophosphamide, which is currently being explored in clinical trials. Additionally, other targeted therapies and multi-kinase inhibitors such as cediranib and anlotinib have shown efficacy in treating refractory metastatic soft-tissue sarcomas, including Ewing Sarcoma.

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Alkylating agents

Seclidemstat + Chemotherapy for Ewing Sarcoma

Phase 1

Waitlist Available

Led By Damon Reed, MD

Research Sponsored by Salarius Pharmaceuticals, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Normal organ and marrow function as defined: ANC ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L with no transfusion 7 days prior to labs, total bilirubin ≤ 1.5 x ULN or > 1.5 x ULN if direct bilirubin is normal, AST and ALT ≤ 3 x ULN, creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60 mL/min/1.73 m^2 for patients with creatinine levels above normal

Age ≥ 12 years and weight ≥ 40 kg

Must not have

Prior small port palliative radiotherapy within 14 days of Cycle 1 Day 1 or within 42 days of Cycle 1 Day 1 from definitive local control radiation

Progressive or symptomatic brain metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening through at least 30 days after end of treatment, up to approximately 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests seclidemstat alone and with other drugs in patients with specific types of sarcoma, especially those who haven't responded to other treatments. The treatment aims to block cancer growth and use chemotherapy to kill cancer cells.

Who is the study for?

This trial is for patients aged 12 and older, weighing at least 40 kg, with specific sarcomas including Ewing or related types that are relapsed/refractory to prior treatments. Participants must have good performance status, adequate organ function, and a life expectancy over four months. They should not have had certain recent treatments or uncontrolled illnesses.

What is being tested?

The trial tests Seclidemstat alone in select sarcoma patients and in combination with Topotecan and Cyclophosphamide for those with Ewing sarcoma. It's an open-label study where all participants receive the drugs without being compared to a placebo or other treatment.

What are the potential side effects?

Potential side effects include reactions from the immune system affecting various organs, blood disorders due to bone marrow suppression by chemotherapy agents like Cyclophosphamide, digestive issues from both chemo drugs, fatigue from overall treatment burden.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood tests show normal organ function and I haven't needed a blood transfusion in the last week.

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I am at least 12 years old and weigh 40 kg or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had targeted radiation therapy recently.

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My brain cancer is getting worse or causing symptoms.

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I have been treated with LSD1 inhibitors for cancer.

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I haven't taken any oral tyrosine kinase inhibitors in the last 14 days.

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I agree to use contraception while on this trial.

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I am HIV-positive and on combination antiretroviral therapy.

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I have a history of cancer.

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I have had a bone marrow or stem cell transplant within the last 84 days.

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I am not currently on any cancer treatment or experimental drugs.

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I have had a condition where my lymphocytes grow abnormally.

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I do not have uncontrolled heart disease or abnormal heart rhythms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening through at least 30 days after end of treatment, up to approximately 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening through at least 30 days after end of treatment, up to approximately 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening through at least 30 days after end of treatment, up to approximately 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and tolerability of seclidemstat (SP-2577) as a single agent and in combination with topotecan and cyclophosphamide measured by dose limiting toxicities and adverse events according to CTCAE version 5.0

Secondary study objectives

Anti-tumor activity as measured according to RECIST 1.1 criteria based upon radiological assessments.

Characterization of the pharmacokinetics of SP-2577 as measured by apparent clearance of seclidemstat

Characterization of the pharmacokinetics of SP-2577 as measured by area under the curve

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Sarcomas with FET-family translocations, including demoplastic small round cell tumorsExperimental Treatment1 Intervention

Twice-daily administration of oral seclidemstat

Group II: Myxoid LiposarcomaExperimental Treatment1 Intervention

Twice-daily administration of oral seclidemstat

Group III: Ewing sarcoma, combination therapyExperimental Treatment3 Interventions

Twice daily administration of seclidemstat in combination with cyclophosphamide and topotecan

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Topotecan

2017

Completed Phase 3

~2890

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Ewing Sarcoma treatments often target the EWS-FLI1 fusion protein, which acts as a transcriptional regulator driving tumor growth. LSD1 inhibitors like Seclidemstat destabilize this protein, reducing its oncogenic activity. Other treatments focus on inhibiting pathways such as IGF-1R and mTOR, which are crucial for cell survival and proliferation. By disrupting these pathways, these therapies induce apoptosis and inhibit tumor growth. Understanding these mechanisms is vital for Ewing Sarcoma patients as it helps in developing targeted therapies that can more effectively combat the disease with potentially fewer side effects.

Inhibition of HDACs reduces Ewing sarcoma tumor growth through EWS-FLI1 protein destabilization.Targeted Therapy-based Combination Treatment in Rhabdomyosarcoma.Ecteinascidin 743 interferes with the activity of EWS-FLI1 in Ewing sarcoma cells.