Clinical trial NCT04581265: Nab-PTX, Ifosfamide and Cisplatin in the Treatment of Pediatric Extracranial Germ Cell Tumor.
Official title: A Multicenter Phase II Clinical Study of Albumin-bound Paclitaxel (Nab-PTX), Ifosfamide and Cisplatin in the Treatment of Pediatric Advanced, Recurrent or Refractory Extracranial Germ Cell Tumor.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Extracranial Germ Cell Tumor, Pediatric
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 43
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age: 1-18 years old;
2. ECOG PS score: 0-1;
3. Patients was confirmed pathologically with malignant germ cell tumor.
4. Patients with tumor progressed, relapsed or refractory after first-line chemotherapy, and complete or partial remission was not achieved after recent treatment.
5. Have at least one measurable lesion defined by RECIST standard;
6. The estimated survival time was more than 6 months;
7. Patients must fully recover from the acute toxicity of previous anticancer chemotherapy:
8. Bone marrow function met the following criteria:

   1. Absolute neutrophil count (ANC) ≥ 1.0 × 109 / L;
   2. Platelet count ≥ 100.0 × 109 / L (not after platelet transfusion);
9. Liver and kidney function should meet the following criteria:

   1. Bilirubin (the sum of bound and unconjugated) ≤ 1.5 × upper limit of normal value (ULN) (corresponding to age). Patients with confirmed Gilbert's syndrome can be classified according to the researcher;
   2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN;
   3. Estimated glomerular filtration rate ≥ 70 ml / min / 1.73 m2 or normal serum creatinine (CR);
10. Adequate pulmonary function: no dyspnea at rest, no exercise intolerance, pulse oxygen saturation \> 94% (if there are clinical symptoms);
11. Cardiac function:

    1. LVEF ≥ 50% was detected by echocardiography;
    2. There was no history of arrhythmia requiring drug intervention before enrollment;
12. Seizures that can be fully controlled without enzyme-induced anticonvulsants;
13. During the study period, they were able to comply with outpatient treatment, laboratory monitoring and necessary clinical visits;
14. 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:

1. Patients with recurrent germ cell tumor were treated by surgery alone previously;
2. Patients with immature teratoma (any grade);
3. Patients with sex cord stroma;
4. HBsAg positive patients;
5. Patients with HIV or syphilis infection;
6. Patients who had received organ transplantation before;
7. Uncontrolled active systemic bacterial, viral or fungal infections;

Primary outcomes:
measure: overall response rate，ORR
timeFrame: From the beginning of observation to the 2 cycles of observation(each cycle is 21 days)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sun Yat-sen University CancerCenter
name: Yizhuo Zhang
role: PRINCIPAL_INVESTIGATOR
References: