CSIIT-Q36: Tucidinostat Plus Etoposide in the Treatment of Neuroblastoma in Childhood.
Study Details
Study Description
Brief Summary
Neuroblastoma is a malignant tumor that develops in infants and kids. Dysregulation of histone acetylation is associated with a series of malignant tumors. Neuroblastoma is caused by defective neural crest differentiation due to abnormal gene regulation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tucidinostat and etoposide
|
Drug: Tucidinostat and etoposide
Tucidinostat: 3+3 design，14 mg/m2，17.5 mg/m2，23 mg/m2 etoposide: 50mg/m2,
|
Outcome Measures
Primary Outcome Measures
- Dose Limiting Toxicity (DLT) [1 year]
Dose-limiting toxicity defined as any Grade 4 hematological toxicity and any > Grade 3 non-hematologic toxicity.
- Maximum Tolerated Dose (MTD) [1 year]
Maximum tolerated dose is highest dose level in which 6 patients treated with at most 1 experiencing DLT.
Secondary Outcome Measures
- Response Rate(ORR) [2 years]
Objective Response Rate（ORR）by RECIST 1.1,the total proportion of patients with complete response（CR）, partial response（PR）
- progression-free survival (PFS) [2 years]
Time from treatment until disease progression or death
- overall survival (OS) [2 years]
Time from treatment until death from any cause
- disease control rate (DCR) [2 years]
The total proportion of patients with complete response（CR）, partial response（PR）and Stable Disease（SD）
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 3~18 years old;
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Patients must have a life expectancy of at least 6 weeks and a Lansky (≤16 years) or Karnofsky (>16 years) score of at least 50;
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Histologically confirmed neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines;
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Patients must have a history of high-risk neuroblastoma, at least one measurable lesions according to the RECIST 1.1;
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Patients who have progressed, recurrent or refractory disease after first-line treatment;
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The residual disease biopsy must be done, if patiens who have persistent disease obtain incomplete response after first line treatment;
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Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study registration；
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Patients have not received enzyme-induced anticonvulsant therapy;
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Patients have not received valproic acid within 30 days before admission;
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ANC ≥ 1.5×109/L, PLT ≥75×109/L;TBIL≤1.5ULN, ALT and AST≤3×ULN（ALT and AST≤5×ULN if liver metastasis）;BUN and Cr≤1.5×ULN 9）LVEF ≥ 50% and QTc≤470 ms.
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Patients' guardians must be willing and able to understand and comply with the protocol for the duration of the study.
Exclusion Criteria:
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Patients with severe cardiovascular disease;
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Patients who have previously received organ transplants;
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Inability to swallow pills;
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Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial;
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Active HIV, hepatitis B or hepatitis C;
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Researchers believe that patients are unsuitable for any other situation in this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sun Yat-sen University | Guangzhou | China |
Sponsors and Collaborators
- Yizhuo Zhang
Investigators
- Principal Investigator: Yizhuo Yizhuo, Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CHIDA-01