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

NCT00467051 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-08-29

Study results available
· View outcomes & findings →

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.

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

Interventions

DRUG

Carboplatin

Given IV

BIOLOGICAL

Filgrastim

Given IV or subcutaneously

DRUG

Ifosfamide

Given IV

OTHER

Laboratory Biomarker Analysis

Optional correlative studies

DRUG

Paclitaxel

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Carlos Rodriguez-Galindo · Children's Oncology Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-05
Primary Completion
2012-03-01
Completion
2018-06-30

Countries

  • United States
  • Australia
  • Canada
  • Puerto Rico

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00467051 on ClinicalTrials.gov