CLINICAL TRIAL SUMMARY

MDACC Study No:COGACNS1123 (clinicaltrials.gov NCT No: NCT01602666)
Title:Phase 2 Trial of Response-Based Radiation Therapy for Patients with Localized Central Nervous System Germ Cell Tumors (CNS GCT)
Principal Investigator:Soumen Khatua
Treatment Agent:Carboplatin; Etoposide; Ifosfamide; MESNA
Study Status:Open
Study Description:The goal of this clinical research study is to learn if using chemotherapy with
carboplatin, etoposide, and (in some patients) ifosfamide, followed by whole
ventricular irradiation (WVI), can help to control the disease while reducing
the frequency and severity of late effects of radiation therapy (such as
learning problems, hormonal problems, and/or other cancers).

Carboplatin is designed to interfere with the growth of cancer cells by
stopping cell division, which may cause the cells to die.

Etoposide and ifosfamide are both designed to slow or stop the growth of cancer
cells.

The goals of this clinical research study are to:
Find out how well treatment with whole ventricular irradiation (WVI) works when
given to children and young adults with NGGCTs whose disease responds well to
standard induction chemotherapy or who have no signs of disease following a
second-look surgery. The WVI will use the same total dose as standard
treatment, but will give a higher dose of radiation to the site of the disease
and a lower dose of radiation to the ventricles. Using WVI instead of CSI or
WBI is experimental. The use of a lower dose of radiation to the ventricles and
a higher dose to the site of disease is also experimental.
Learn about the neuropsychological (for example, thinking, learning, and
remembering) and behavioral functioning of children and young adults being
treated for newly diagnosed localized NGGCT.
Find out if using chemotherapy with carboplatin and etoposide followed by WVI
will work well to get rid of the newly diagnosed localized CNS germinoma for as
long as possible, while reducing the frequency and severity of late effects of
radiation therapy.
Find out if using a lower dose of radiation after chemotherapy in subjects
whose disease responds well to the chemotherapy will work as well as using the
standard dose of radiation to get rid of the newly diagnosed localized CNS
germinoma for as long as possible.
Learn about the neuropsychological (for example, thinking, learning, and
remembering) and behavioral functioning of children and young adults being
treated for newly diagnosed localized CNS germinoma.

(Comment from Research Team: We know that some of this info is included above.
However, the goals that we just added are more consistent with the COG consent.
We do not want this info duplicated, just wanted to show the difference and
include the new test instead.)

This study is called a clinical trial. A clinical trial is a research study
involving treatment of a disease in human patients. This study is organized by
Children’s Oncology Group (COG). COG is an international research group that
conducts clinical trials for children with cancer. More than 200 hospitals in
North America, Australia, New Zealand, and Europe are members of COG.

Hide details for General InformationGeneral Information

Disease Group:CNS; Pediatrics
Phase of Study:Phase II
Treatment Agents:Carboplatin
Etoposide
Ifosfamide
MESNA
Treatment Location:Both at MDACC & and Other Sites
Estimated Length of Stay in Houston:
Supported By:N/A
Return Visit:
Home Care:


Hide details for Study Contact InformationStudy Contact Information

Physician Name:Soumen Khatua
Dept:Pediatrics
For Clinical Trial Enrollment:713-792-6620
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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