Clinical Trial of VIM With VIT in Children With Relapsed and Refractory Soft Tissue Sarcoma.

NCT06514313 | Recruiting Phase 2

• 1 other identifier: CSPC-DED-STS-K01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Explore the efficacy and safety of mitoxantrone liposome combined with irinotecan and vincristine (VIM) in the treatment of relapsed/refractory soft tissue sarcoma in children.

Conditions

Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Objective response rate (ORR) after 2 cycles of chemotherapy with VIM or VIT regimen, including complete response (CR) and partial response (PR)

  Up to 2 cycles of chemotherapy (each cycle is 21 days)

Secondary Outcomes (4)

• Objective response rate (ORR)

  Up to 4 cycles of chemotherapy (each cycle is 21 days)

• Disease control rate (DCR)

  Up to 4 cycles of chemotherapy (each cycle is 21 days)

• Progression-free survival (PFS)

  From date of radomization unit the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 moths.

• Overall survival (OS)

  From date of radomization unit the date of first documented date of death from any cause, assessed up to 24 moths

Other Outcomes (1)

• Circulating tumor DNA (ctDNA) .

  Assessed up to 24 moths.

Study Arms (2)

VIM

EXPERIMENTAL

Mitoxantrone Hydrochloride Liposome combined with Irinotecan and Vincristine.

Drug: Mitoxantrone Hydrochloride Liposome+Irinotecan+Vincristine

VIT

ACTIVE COMPARATOR

Temozolomide combined with Irinotecan and Vincristine.

Drug: Temozolomide+Irinotecan+Vincristine

Interventions

Mitoxantrone Hydrochloride Liposome+Irinotecan+Vincristine DRUG

Mitoxantrone hydrochloride liposome will be administered by an intravenous infusion , 4 cycles.

VIM

Temozolomide+Irinotecan+Vincristine DRUG

Q3W, 4 cycles

VIT

Eligibility Criteria

• Age: 2 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years ≤age≤21 years, no gender limitation.
• The Karnofsky (≥16 years old) or Lansky (\< 16 years old) physical status score is at least 70.
• The expected survival time is not less than 12 weeks.
• Heart function: a) Cardiac COLOR ultrasound detection LVEF≥ 50%; b) ECG suggests no myocardial ischemia; c) No history of arrhythmia requiring drug intervention before enrollment.
• Pathological results for patients of soft tissue sarcoma.
• Patients with rhabdomyosarcoma are limited to first -, second -, and third-line treatment, and patients with other pathological subtypes are limited to progression, recurrence, or refractory after first-line treatment, with refractory defined as failure to achieve complete or partial response to the most recent treatment.
• Measurable lesions (according to RECIST 1.1 standards, measurable lesions have not received radiotherapy, freezing and other local treatments).
• The patient must fully recover from the acute toxic effects of all previous anticancer chemotherapy.
• Good blood and organ function.
• During study participation, patients are able to adhere to outpatient treatment, laboratory monitoring, and necessary clinical visits.
• The parent/guardian of the child or adolescent subject is capable of understanding, agreeing to, and signing the study Informed consent (ICF) and the applicable child consent form prior to initiating any program-related procedures; Subject is capable of expressing consent with parental/guardian consent (if applicable).

You may not qualify if:

• Once received mitoxantrone or mitoxantrone liposomes.
• Patients who had received previous VIT (irinotecan + temozolomide + vincristine) chemotherapy.
• Previous treatment with adriamycin or other anthracyclines with a total cumulative dose of adriamycin \> 360 mg/m\^2; Or patients with cardiac disease caused by previous anthracyclines.
• Receiving or not being able to discontinue P450 enzyme-induced anticonvulsant drugs (e.g., phenytoin, carbamazepine, etc.) within 4 weeks or 5 half-life periods prior to enrollment.
• Previous or concurrent clinical significance of active cardiovascular diseases.
• Severe chronic skin diseases in the past.
• Previous allergic asthma or severe allergic disease.
• Uncontrolled hypertension and diabetes.
• Have a history of other tumors, except cured cervical cancer or basal cell carcinoma of the skin.
• Active hepatitis B or hepatitis C infection.
• HIV or syphilis infected patients.
• Patients who have previously received organ transplants.
• Uncontrolled active systemic bacterial, viral, or fungal infection.
• Contraindications to high-dose hormone use, such as uncontrolled hyperglycemia, gastric ulcers, or psychiatric disorders.
• Severe neurological or psychiatric history, including epilepsy or autism.

Sponsors & Collaborators

• Yizhuo Zhang: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Yizhuo Zhang, PhD

CONTACT

020-87342460; zhangyzh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 23, 2024
• Study Start: July 3, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)