Nab-PTX, Ifosfamide and Cisplatin in the Treatment of Pediatric Extracranial Germ Cell Tumor.

NCT ID: NCT04581265

Last Updated: 2020-10-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-10
• Study Completion Date: 2024-05-10

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.

Conditions

Extracranial Germ Cell Tumor, Pediatric

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

nab-PTX, ifosfamide and cisplatin

albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatin in the treatment of pediatric advanced, recurrent or refractory extracranial germ cell tumor.

Group Type: EXPERIMENTAL

albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatin

Intervention Type: 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.

Interventions

albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatin

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.

Intervention Type: DRUG

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;

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yizhuo Zhang

Director of department of pediatric cancer,Principal Investigator,Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yizhuo Zhang

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University CancerCenter

Central Contacts

Yizhuo Zhang

Role: CONTACT

zhangyzh@sysucc.org.cn

020-87342459

Other Identifiers

nab-PTX-sun

Identifier Type: -

Identifier Source: org_study_id