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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:

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.


Sponsor: Children's Oncology Group

Current Primary Outcome: Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria [ Time Frame: At baseline (day 1) and after completion of protocol therapy (2 cycles or 42 days) ]

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.


Original Primary Outcome: Response as measured by RECIST

Current Secondary Outcome: Toxicity as Measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events ( CTCAE) Version 4.0 [ Time Frame: During and after completion of study treatment ]

All patients who experience any grade 2 or higher toxicity at any time during the two treatment cycles or who receive at least all required Ifosfamide therapy after enrollment will be considered evaluable for toxicity. The descriptions and grading scales found in the revised NCI CTCAE version 4 will be used.


Original Secondary Outcome: Toxicity as measured by NCI CTCAE v3.0

Information By: Children's Oncology Group

Dates:
Date Received: April 25, 2007
Date Started: November 2007
Date Completion:
Last Updated: February 7, 2017
Last Verified: February 2017