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The purpose is to evaluate the effectiveness and safety of albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatin in the treatment of children patients with advanced, recurrent or refractory extracranial germ cell tumor.
Children patients with advanced, recurrent or refractory extracranial germ cell tumor were treated with albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatin . This is a multi-center and single arm phase II clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nab-PTX, ifosfamide and cisplatin | Experimental | albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatin in the treatment of pediatric advanced, recurrent or refractory extracranial germ cell tumor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatin | Drug | Participants received a single dose of albumin-bound paclitaxel (nab-PTX) 270mg/m2/d, administered intravenously (IV) on Day 1; Ifosfamide 1.2g/m2/d administered intravenously (IV) on Day 2-6; Cisplatin 20mg/m2/d administered intravenously (IV) on Day 2-6. |
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate,ORR | Percentage of participants who experienced an overall response (overall response rate,ORR) of albumin-binding paclitaxel, ifosfamide, cisplatin regimen in the treatment of advanced, recurrent and refractory children with extracranial germ cell tumor. | From the beginning of observation to the 2 cycles of observation(each cycle is 21 days) |
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Inclusion Criteria:
Age: 1-18 years old;
ECOG PS score: 0-1;
Patients was confirmed pathologically with malignant germ cell tumor.
Patients with tumor progressed, relapsed or refractory after first-line chemotherapy, and complete or partial remission was not achieved after recent treatment.
Have at least one measurable lesion defined by RECIST standard;
The estimated survival time was more than 6 months;
Patients must fully recover from the acute toxicity of previous anticancer chemotherapy:
Bone marrow function met the following criteria:
Liver and kidney function should meet the following criteria:
Adequate pulmonary function: no dyspnea at rest, no exercise intolerance, pulse oxygen saturation > 94% (if there are clinical symptoms);
Cardiac function:
Seizures that can be fully controlled without enzyme-induced anticonvulsants;
During the study period, they were able to comply with outpatient treatment, laboratory monitoring and necessary clinical visits;
Parents / guardians of child or adolescent subjects have the ability to understand, agree and sign the study informed consent form (ICF) and the applicable child consent form before starting any program related procedures; subject has the ability to express consent (when applicable) with the consent of parents / guardians.
Exclusion Criteria:
Patients with any of the following items will not be enrolled in this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yizhuo Zhang | Contact | 020-87342459 | zhangyzh@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yizhuo Zhang | Sun Yat-sen University CancerCenter | Principal Investigator |
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| ID | Term |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| D007069 | Ifosfamide |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
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|
| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003520 | Cyclophosphamide |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |