MDACC Study No:COGACNS0332 ( NCT No: NCT00392327)
Title:Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients
Principal Investigator:Soumen Khatua
Treatment Agent:Carboplatin; Cyclophosphamide; Filgrastim; Isotretinoin; Radiation; Vincristine
Study Status:Closed
Study Description:The overall goal of this study was to compare the effects, good and/or bad, of
adding the chemotherapy drugs carboplatin and/or isotretinoin to the standard
treatment combination of chemotherapy and radiation, in treating patients with
high-risk medulloblastoma. Researchers want to find out if adding one or both
chemotherapy drugs is more effective in treating the disease than giving
standard therapy alone. As of January 27, 2015, enrollment was suspended when
the results showed that isotretinoin was not better than standard therapy with
or without carboplatin. As a result, patients who enroll on this study will no
longer receive isotretinoin.

The main aim of this study is:
To find out if giving the drug carboplatin along with radiation therapy is more
effective than giving radiation therapy alone.

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:Brain; Pediatrics
Phase of Study:Phase III
Treatment Agents:Carboplatin
Treatment Location:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated Length of Stay in Houston:Patients will be hospitalized for about 3 days each month during maintenance
Supported By:Children's Oncology Group
Return Visit:Patients will receive radiation treatment daily Monday-Friday for the first 6
weeks along with chemo;
pts will also come to pedi clinic weekly for labs and a physical exam
Home Care:Filgrastim (G-CSF) may be given at home as a subcutaneous injection

Hide details for Study Contact InformationStudy Contact Information

Physician Name:Soumen Khatua
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.)

Show details for Study Objectives / OutcomesStudy Objectives / Outcomes
Show details for Study Status InformationStudy Status Information
Show details for Enrollment EligibilityEnrollment Eligibility
Show details for Resources and LinksResources and Links
Show details for ResultsResults