Back to resultsPaclitaxel/Ifosfamide/Cisplatin Chemotherapy for High Risk Pediatric Germ Cell Tumor
Primary Purpose
Pediatric Germ Cell Tumor
Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
TIP treatment (paclitaxel/ifosfamide/cisplatin)
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Germ Cell Tumor
Eligibility Criteria
Inclusion Criteria:
- Over 1 year old and less than 20 years old
- Pathologically or cytologically diagnosed germ cell tumor
- Germ cell tumor which has not been treated previously
- Higher than stage II (stage I should be excluded)
Pathologic type
- embryonal carcinoma
- choriocarcinoma
- yolk sac tumor
- teratoma with malignant germ cell tumor elements
High risk definition
- More than 11 years old, male or female
Less than 11 years old, male or female
- Extragonodal germ cell tumor, stage III
- Extragonodal germ cell tumor, stage IV
- Ovarian germ cell tumor, stage IV
- More than 8 weeks of life expectancy
- performance level : ECOG Performance score 0, 1, or 2
- informed consent should be obtained
Exclusion Criteria:
- pregnancy or lactating patients (fertile men or women should agree to avoid pregnancy during the trial period)
- previously reported allergy or hypersensitivity to trial chemotherapeutic agent
- severe hypersensitivity to the agent containing Cremophor R EL (polyoxyethylated castor oil)
Acceptable organ functions
- Bone marrow : Absolute neutrophil count >=1000/µL , platelet >= 100000/µL
- Renal function : serum creatinine ≤ 1.5 x upper limit of normal (ULN)
- Hepatic function : total bilirubin ≤ 1.5 x ULN, ALT ≤ 3.0 x UNL
- Cardiac Function : Ejection fraction ≥ 50%
- Uncontrolled infection
- Uncontrolled urinary obstruction
- Uncontrolled cystitis
Followings will be excluded
- Mature teratoma
- Gliomatosis Peritonei
- Low Risk Germ Cell Tumor
- testicular stage I
- ovarian stage I
- recurrent, refractory tumor
- Concomitant other trial agent beside the agents in this trial
Concomitant chemotherapeutic agents besides the agents in this trial
- Concomitant tumor other than germ cell tumor
- Other trial agents
- Other chemotherapeutic agents
Sites / Locations
- Yonsei University Health System, Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TIP treatment arm
Arm Description
Outcomes
Primary Outcome Measures
Complete Response Rate
Secondary Outcome Measures
Overall Response Rate
Complete Response Rate
Overall Survival
Event Free Survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05455918
Brief Title
Paclitaxel/Ifosfamide/Cisplatin Chemotherapy for High Risk Pediatric Germ Cell Tumor
Official Title
Non-randomized, Phase II, Open-label Study for Efficacy and Safety of Consolidation Paclitaxel/Ifosfamide/Cisplatin (TIP) Chemotherapy for High Risk Pediatric Germ Cell Tumor
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2020 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Germ cell tumor has generally good prognosis, but high risk germ cell tumor has still very poor prognosis. There remains the need of further improvement with other chemotherapy strategy. Especially more than 11 years old, mediastinal germ cell tumor, stage 3 or 4 extragonodal germ cell tumor or the remained tumor after the primary treatment are the group with the poorest prognosis.
Paclitaxel is widely used chemotherapeutic agent in adults and the experience of the agent has also been accumulated in children. The paclitaxel, ifosfamide, cisplatin (TIP) regimen has been used 2nd-line treatment for germ cell tumor and there is some promising result of the role of TIP in first line germ cell tumor treatment. In high risk pediatric germ cell tumor patients, TIP regimen will be able to reduce lung toxicity from the bleomycin as the standard regimen and to improve the survival. In this trial, the efficacy and safety of TIP as the first line treatment for germ cell tumor will be elucidated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Germ Cell Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TIP treatment arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TIP treatment (paclitaxel/ifosfamide/cisplatin)
Intervention Description
Paclitaxel 240mg/m2/day D1 (total 240mg/m2) Ifosfamide 1.5g/m2/day D2~5 (total 6g/m2) Cisplatin 25mg/m2/day D2~5 (total 100mg/m2)
Primary Outcome Measure Information:
Title
Complete Response Rate
Time Frame
12weeks
Secondary Outcome Measure Information:
Title
Overall Response Rate
Time Frame
12 weeks and 18 weeks
Title
Complete Response Rate
Time Frame
18 weeks
Title
Overall Survival
Time Frame
3 years
Title
Event Free Survival
Time Frame
3 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Over 1 year old and less than 20 years old
Pathologically or cytologically diagnosed germ cell tumor
Germ cell tumor which has not been treated previously
Higher than stage II (stage I should be excluded)
Pathologic type
embryonal carcinoma
choriocarcinoma
yolk sac tumor
teratoma with malignant germ cell tumor elements
High risk definition
More than 11 years old, male or female
Less than 11 years old, male or female
Extragonodal germ cell tumor, stage III
Extragonodal germ cell tumor, stage IV
Ovarian germ cell tumor, stage IV
More than 8 weeks of life expectancy
performance level : ECOG Performance score 0, 1, or 2
informed consent should be obtained
Exclusion Criteria:
pregnancy or lactating patients (fertile men or women should agree to avoid pregnancy during the trial period)
previously reported allergy or hypersensitivity to trial chemotherapeutic agent
severe hypersensitivity to the agent containing Cremophor R EL (polyoxyethylated castor oil)
Acceptable organ functions
Bone marrow : Absolute neutrophil count >=1000/µL , platelet >= 100000/µL
Renal function : serum creatinine ≤ 1.5 x upper limit of normal (ULN)
Hepatic function : total bilirubin ≤ 1.5 x ULN, ALT ≤ 3.0 x UNL
Cardiac Function : Ejection fraction ≥ 50%
Uncontrolled infection
Uncontrolled urinary obstruction
Uncontrolled cystitis
Followings will be excluded
Mature teratoma
Gliomatosis Peritonei
Low Risk Germ Cell Tumor
testicular stage I
ovarian stage I
recurrent, refractory tumor
Concomitant other trial agent beside the agents in this trial
Concomitant chemotherapeutic agents besides the agents in this trial
Concomitant tumor other than germ cell tumor
Other trial agents
Other chemotherapeutic agents
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jung Woo Han
Phone
82-2-2228-2050
Email
JWHAN@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung Woo Han
Organizational Affiliation
Department of Pediatric Hematology and Oncology, Yonsei Cancer Center, Yonsei University Health System.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung Woo Han
Phone
82-2-2228-2050
Email
JWHAN@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Paclitaxel/Ifosfamide/Cisplatin Chemotherapy for High Risk Pediatric Germ Cell Tumor
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