Actively Recruiting
Clinical Trial of VIM With VIT in Children With Relapsed and Refractory Soft Tissue Sarcoma.
Led by Yizhuo Zhang · Updated on 2024-07-23
110
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Clinical Trial of VIM With VIT in Children With Relapsed and Refractory Soft Tissue Sarcoma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 2 and 21 years, any gender
- Karnofsky score 60 years old) or Lansky score (<16 years old) of at least 70
- Expected survival of at least 12 weeks
- Heart function: LVEF 6 50%, no myocardial ischemia on ECG, no arrhythmia requiring medication before enrollment
- Pathological diagnosis of soft tissue sarcoma
- Rhabdomyosarcoma patients limited to first, second, or third-line treatment
- Other sarcoma types with progression, recurrence, or refractory after first-line treatment
- Measurable lesions per RECIST 1.1 not previously treated with local therapies
- Complete recovery from acute toxic effects of prior chemotherapy
- Adequate blood and organ function
- Ability to adhere to outpatient treatment, labs, and clinical visits
- Parent/guardian able to understand and sign informed consent; subject able to provide consent if applicable
You will not qualify if you...
- Prior treatment with mitoxantrone or mitoxantrone liposomes
- Previous VIT chemotherapy
- Prior anthracycline treatment with cumulative adriamycin dose >360 mg/m2 or anthracycline-related cardiac disease
- Use of P450 enzyme-inducing anticonvulsants within 4 weeks before enrollment
- Active or significant cardiovascular disease
- Severe chronic skin diseases
- History of allergic asthma or severe allergy
- Uncontrolled hypertension or diabetes
- History of other tumors except cured cervical or basal cell carcinoma
- Active hepatitis B or C infection
- HIV or syphilis infection
- Prior organ transplant
- Uncontrolled active systemic infections
- Contraindications to high-dose hormone use
- Severe neurological or psychiatric history including epilepsy or autism
- Pregnant, lactating, or unwilling to use contraception if of childbearing potential
- Other conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Y
Yizhuo Zhang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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