NCT00467051

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. Determine the response rate in pediatric patients with recurrent or resistant malignant germ cell tumors (GCT) treated with paclitaxel, ifosfamide, and carboplatin. SECONDARY OBJECTIVES: I. Determine the toxicity of this regimen in these patients. II. To Collect tissue for the tumor bank that will aid in the identification of the biological characteristics of recurrent GCT. OUTLINE: This is a multicenter study. 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. After completion of study treatment, patients are followed periodically for up to 5 years.

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

Type	Name	Description
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

Timeline

• Start date: 2007-11-05
• Primary completion: 2012-03-01
• Completion: 2018-06-30
• First posted: 2007-04-27
• Last updated: 2018-08-29
• Results posted: 2015-03-20

Locations

95 sites across 4 countries: United States, Australia, Canada, Puerto Rico