Extracranial Germ Cell Tumor, PediatricPhase 2NCT04581265
Nab-PTX, Ifosfamide and Cisplatin in the Treatment of Pediatric Extracranial Germ Cell Tumor.
A Phase 2 study testing albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatin in people with Extracranial Germ Cell Tumor, Pediatric, run by Sun Yat-sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Extracranial Germ Cell Tumor, Pediatric
- What is being tested?
- albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2020to 10 May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
Trial locations and contacts
No sites are listed yet.
About this study
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.
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.
Read the 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
- Being tested
- albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| nab-PTX, ifosfamide and cisplatin | Experimental | albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatin in the treatment of pediatric advanced, recurrent or refractory extracranial germ cell tumor. Receives: Drug: albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the beginning of observation to the 2 cycles of observation(each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start10 Nov 2020 (estimated)
- Primary completion10 Nov 2023 (estimated)
- Study completion10 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracranial Germ Cell Tumor, PediatricStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yizhuo Zhang, Sun Yat-sen University
- Investigators
- Yizhuo Zhang, Principal investigator, Sun Yat-sen University CancerCenter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581265
- Sponsor's protocol ID
- nab-PTX-sun
- Status last verified
- Oct 2020
- First submitted
- 13 Sep 2020
- Last updated
- 9 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04581265
- Acronym / sponsor ID
- nab-PTX-sun
- Conditions
- Extracranial Germ Cell Tumor, Pediatric
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Nov 2020 (estimated)
- Primary completion
- 10 Nov 2023 (estimated)
- Study completion
- 10 May 2024 (estimated)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nab-PTX, ifosfamide and cisplatin | Experimental | Drug: albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatinalbumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatin in the treatment of pediatric advanced, recurrent or refractory extracranial germ cell tumor. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (21 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatinParticipants 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. | Drug | nab-PTX, ifosfamide and cisplatin |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
Related trials for Extracranial Germ Cell Tumor, Pediatric
RecruitingPhase 3
Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors
Childhood Extracranial Germ Cell Tumor, Extragonadal Embryonal Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yizhuo Zhang principal investigator
Sun Yat-sen University CancerCenter
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatin in people with Extracranial Germ Cell Tumor, Pediatric, run by Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yizhuo Zhang (020-87342459, zhangyzh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate，ORR (time frame: From the beginning of observation to the 2 cycles of observation(each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.