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Paclitaxel/Ifosfamide/Cisplatin Chemotherapy for High Risk Pediatric Germ Cell Tumor

Sponsor
Yonsei University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05455918
Collaborator
(none)
42
Enrollment
1
Location
1
Arm
94.2
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: TIP treatment (paclitaxel/ifosfamide/cisplatin)
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 26, 2020
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: TIP treatment arm

Drug: TIP treatment (paclitaxel/ifosfamide/cisplatin)
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)

Outcome Measures

Primary Outcome Measures

  1. Complete Response Rate [12weeks]

Secondary Outcome Measures

  1. Overall Response Rate [12 weeks and 18 weeks]

  2. Complete Response Rate [18 weeks]

  3. Overall Survival [3 years]

  4. Event Free Survival [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 20 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

  1. embryonal carcinoma

  2. choriocarcinoma

  3. yolk sac tumor

  4. teratoma with malignant germ cell tumor elements

  • High risk definition

  1. More than 11 years old, male or female

  2. Less than 11 years old, male or female

  3. Extragonodal germ cell tumor, stage III

  4. Extragonodal germ cell tumor, stage IV

  5. 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

  1. Bone marrow : Absolute neutrophil count >=1000/µL , platelet >= 100000/µL

  2. Renal function : serum creatinine ≤ 1.5 x upper limit of normal (ULN)

  3. Hepatic function : total bilirubin ≤ 1.5 x ULN, ALT ≤ 3.0 x UNL

  4. Cardiac Function : Ejection fraction ≥ 50%

  5. Uncontrolled infection

  6. Uncontrolled urinary obstruction

  7. Uncontrolled cystitis

  • Followings will be excluded

  1. Mature teratoma

  2. Gliomatosis Peritonei

  3. Low Risk Germ Cell Tumor

  4. testicular stage I

  5. ovarian stage I

  6. recurrent, refractory tumor

  • Concomitant other trial agent beside the agents in this trial

  • Concomitant chemotherapeutic agents besides the agents in this trial

  1. Concomitant tumor other than germ cell tumor

  2. Other trial agents

  3. Other chemotherapeutic agents

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yonsei University Health System, Severance Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Yonsei University

Investigators

  • Principal Investigator: Jung Woo Han, Department of Pediatric Hematology and Oncology, Yonsei Cancer Center, Yonsei University Health System.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yonsei University
ClinicalTrials.gov Identifier:
NCT05455918
Other Study ID Numbers:
  • 4-2020-0658
First Posted:
Jul 13, 2022
Last Update Posted:
Jul 13, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms, Germ Cell and Embryonal
Paclitaxel
Ifosfamide

Study Results

No Results Posted as of Jul 13, 2022