CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Carboplatin +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00467051
NCT00467051Phase 2Completed
CompareCT.gov

Treatment of Recurrent or Resistant Pediatric Malignant Germ Cell Tumors With Paclitaxel, Ifosfamide and Carboplatin

Children's Oncology Group·interventional·Posted Apr 27, 2007·Updated Aug 29, 2018

In Brief

A Phase 2 clinical trial evaluating Carboplatin, Filgrastim, and 3 other interventions for Childhood Extracranial Germ Cell Tumor and 15 related conditions. Completed, enrolled 20 participants across 95 sites in 4 countries.

Detailed Summary

This phase II trial is studying how well giving combination chemotherapy works in treating young patients with recurrent or resistant malignant germ cell tumors. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChildhood Extracranial Germ Cell Tumor, Childhood Extragonadal Malignant Germ Cell Tumor, Childhood Malignant Ovarian Germ Cell Tumor, Childhood Malignant Testicular Germ Cell Tumor, Ovarian Choriocarcinoma, Ovarian Embryonal Carcinoma, Ovarian Yolk Sac Tumor, Recurrent Childhood Malignant Germ Cell Tumor, Recurrent Malignant Testicular Germ Cell Tumor, Recurrent Ovarian Germ Cell Tumor, Testicular Choriocarcinoma, Testicular Embryonal Carcinoma, Testicular Mixed Choriocarcinoma and Embryonal Carcinoma, Testicular Mixed Choriocarcinoma and Yolk Sac Tumor, Testicular Mixed Embryonal Carcinoma and Yolk Sac Tumor, Testicular Yolk Sac Tumor
CountriesAustralia, Canada, Puerto Rico, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 27, 2007
Enrollment StartNov 5, 2007
Primary CompletionMar 1, 2012
Study CompletionJun 30, 2018
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 19.2 years ago

Interventions

Carboplatindrug

Given IV

Filgrastimbiological

Given IV or subcutaneously

Ifosfamidedrug

Given IV

Laboratory Biomarker Analysisother

Optional correlative studies

Paclitaxeldrug

Given IV