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

Last updated: October 6, 2020
Sponsor: Sun Yat-sen University
Overall Status: Active - Not Recruiting

Phase

2

Condition

Testicular Cancer

Treatment

N/A

Clinical Study ID

NCT04581265
nab-PTX-sun
  • Ages 1-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 anticancerchemotherapy:

  8. Bone marrow function met the following criteria:

  9. Absolute neutrophil count (ANC) ≥ 1.0 × 109 / L;

  10. Platelet count ≥ 100.0 × 109 / L (not after platelet transfusion);

  11. Liver and kidney function should meet the following criteria:

  12. 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 beclassified according to the researcher;

  13. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN;

  14. Estimated glomerular filtration rate ≥ 70 ml / min / 1.73 m2 or normal serumcreatinine (CR);

  15. Adequate pulmonary function: no dyspnea at rest, no exercise intolerance, pulse oxygensaturation > 94% (if there are clinical symptoms);

  16. Cardiac function:

  17. LVEF ≥ 50% was detected by echocardiography;

  18. There was no history of arrhythmia requiring drug intervention before enrollment;

  19. Seizures that can be fully controlled without enzyme-induced anticonvulsants;

  20. During the study period, they were able to comply with outpatient treatment,laboratory monitoring and necessary clinical visits;

  21. 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 consentform before starting any program related procedures; subject has the ability toexpress consent (when applicable) with the consent of parents / guardians.

Exclusion

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;

Study Design

Total Participants: 43
Study Start date:
November 10, 2020
Estimated Completion Date:
May 10, 2024

Study 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.