- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04581265
Nab-PTX, Ifosfamide and Cisplatin in the Treatment of Pediatric Extracranial Germ Cell Tumor.
October 6, 2020 updated by: Yizhuo Zhang, Sun Yat-sen University
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yizhuo Zhang
- Phone Number: 020-87342459
- Email: zhangyzh@sysucc.org.cn
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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:
- Absolute neutrophil count (ANC) ≥ 1.0 × 109 / L;
- Platelet count ≥ 100.0 × 109 / L (not after platelet transfusion);
Liver and kidney function should meet the following criteria:
- 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;
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN;
- Estimated glomerular filtration rate ≥ 70 ml / min / 1.73 m2 or normal serum creatinine (CR);
- Adequate pulmonary function: no dyspnea at rest, no exercise intolerance, pulse oxygen saturation > 94% (if there are clinical symptoms);
Cardiac function:
- LVEF ≥ 50% was detected by echocardiography;
- There was no history of arrhythmia requiring drug intervention before enrollment;
- 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:
- Patients with recurrent germ cell tumor were treated by surgery alone previously;
- Patients with immature teratoma (any grade);
- Patients with sex cord stroma;
- HBsAg positive patients;
- Patients with HIV or syphilis infection;
- Patients who had received organ transplantation before;
- Uncontrolled active systemic bacterial, viral or fungal infections;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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.
|
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
Time Frame: From the beginning of observation to the 2 cycles of observation(each cycle is 21 days)
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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