NCT00467051|CompletedPhase 2Results

Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell Tumors

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

Children's Oncology Group ClinicalTrials.gov

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5 other identifiers

AGCT0521NCI-2009-00374COG-AGCT0521CDR0000542424U10CA098543

Study Type

interventional

Target

Locations

4 countries

Sites

Timeline

RegisteredApr 2007

StartedNov 2007

CompletionJun 2018

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Nov 2007

Longer than P75 for phase_2

Geographic Reach

4 countries

95 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10.7 years study duration

First Submitted

Initial submission to the registry

April 25, 2007

Completed

2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed

6 months until next milestone

Study Start

First participant enrolled

November 5, 2007

Completed

4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed

3.1 years until next milestone

Results Posted

Study results publicly available

March 20, 2015

Completed

3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed

Last Updated

August 29, 2018

Status Verified

October 1, 2017

Enrollment Period

4.3 years

First QC Date

April 25, 2007

Results QC Date

March 11, 2015

Last Update Submit

August 27, 2018

Conditions

Childhood 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

Outcome Measures

Primary Outcomes (1)

Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Patients who demonstrate a PR or CR, as defined below, will be considered as responders. RECIST criteria: CR (complete response) = disappearance of all target lesions, PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions, PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions and SD (stable disease) = small changes that do not meet above criteria.
At baseline (day 1) and after completion of protocol therapy (2 cycles or 42 days)

Secondary Outcomes (1)

The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity.
Two cycles of chemotherapy; expected to be 42 days of treatment.

Study Arms (1)

Treatment (chemotherapy, biological therapy)

EXPERIMENTAL

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

Drug: CarboplatinBiological: FilgrastimDrug: IfosfamideOther: Laboratory Biomarker AnalysisDrug: Paclitaxel

Interventions

CarboplatinDRUG

Given IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo