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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Extracranial Germ Cell Tumor, Pediatric
• Intervention / Treatment: Drug: albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 43
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yizhuo Zhang; Phone Number: 020-87342459; Email: zhangyzh@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 10, 2020
• Primary Completion (Anticipated): November 10, 2023
• Study Completion (Anticipated): May 10, 2024

Study Registration Dates

• First Submitted: September 13, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 9, 2020

Study Record Updates

• Last Update Posted (Actual): October 9, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Germ Cell and Embryonal; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Antineoplastic Agents, Phytogenic; Paclitaxel; Ifosfamide; Albumin-Bound Paclitaxel
• Other Study ID Numbers: nab-PTX-sun

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No