Entinostat for pediatric soft tissue sarcoma with PAX abnormalities

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional trial in children and adolescents with malignant soft tissue sarcoma that harbor PAX-family gene abnormalities. Cohort 1 will receive entinostat after prior therapy as consolidation in patients who achieved CR or PR. Cohort 2 will receive entinostat with alternating VAC/VTC chemotherapy in those with recurrent or progressive disease, with an option for a tailored regimen if standard VAC/VTC is intolerable or ineffective. The study aims to assess safety and preliminary antitumor activity of entinostat, alone or in combination. Enrollment is limited to participants aged 1 to 18 years with adequate organ function and performance status, treated at Beijing Tongren Hospital.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age \>1 year and ≤18 years.
2. Histologically confirmed malignant soft tissue sarcoma that is PAX3-FOXO1- or PAX7-FOXO1-fusion positive or has another PAX-family gene abnormality.
3. Clinical disease status: (a) monotherapy cohort: completion of standard backbone chemotherapy and/or radiotherapy with a favorable clinical response (CR or PR); (b) combination cohort: inadequate response following standard chemotherapy and/or radiotherapy, or recurrent/progressive disease.
4. Karnofsky Performance Status (KPS) ≥50 or Lansky Performance Status (LPS) ≥50.
5. Adequate bone marrow function: ANC ≥0.5 × 10\^9/L, platelet count ≥50 × 10\^9/L, hemoglobin ≥70 g/L, and WBC ≥1.5 × 10\^9/L, with values not exceeding the upper limit of normal.
6. Life expectancy of at least 6 months.
7. Written informed consent obtained.

Exclusion Criteria:

1. Previous hematopoietic stem cell transplantation or organ transplantation.
2. Participation in another drug clinical trial within 2 months before enrollment.
3. Uncontrolled infection or body temperature ≥38°C.
4. Total bilirubin, ALT, and AST \>2.5 × the upper limit of normal.
5. Serum creatinine \>2.0 × the upper limit of normal.
6. Any other condition considered by the investigator to constitute a contraindication to study participation.

Where it's running

• Beijing Tongren Hospital
  Beijing, Beijing Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.