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A Phase III Study Assessing Carboplatin and/or Isotretinoin plus Radiation in Patients with Supratentorial Primitive Neuroectodermal Tumor or High-Risk Medulloblastoma

[Protocol 07-174]

Full Title :

EFFICACY OF CARBOPLATIN ADMINISTERED CONCOMITANTLY WITH RADIATION AND ISOTRETINOIN AS A PRO-APOPTOTIC AGENT IN OTHER THAN AVERAGE RISK MEDULLOBLASTOMA/PNET PATIENTS - A GROUPWIDE PHASE III STUDY (COG ACNS0332)

Purpose :

Supratentorial primitive neuroectodermal tumor (PNET) and medulloblastoma are types of brain tumors. Medulloblastoma is considered to be high risk if surgery could not remove the entire tumor, if the cerebrospinal fluid has tumor cells in it, or if there are additional sites of tumor cells in the brain or spine. The purpose of this phase III Children's Oncology Group study is to evaluate the effectiveness of adding one or two types of anticancer drugs (carboplatin and isotretinoin) to standard therapy for these cancers.

Standard treatment includes surgery, radiation therapy to the brain and spinal cord, and chemotherapy. The first medicine being added to this regimen, carboplatin, may be given daily during radiation therapy. The second medicine being added, isotretinoin, may be given after radiation therapy as part of the chemotherapy administered after radiation.

In this study, patients will be randomly assigned to receive standard therapy alone, standard therapy with carboplatin or isotretinoin, or standard therapy with carboplatin and isotretinoin. Researchers will also examine the effects of treatment on each patient's quality of life and brain function.

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

• Patients must have a confirmed diagnosis of supratentorial PNET or high-risk medulloblastoma that has not yet been treated with chemotherapy or radiation therapy.
• Patients must be between the ages of 3 and 21 (inclusive).

For more information and to inquire about eligibility for this study, please contact Dr. Stephen W. Gilheeney at 212-639-3973 or Dr. Yasmin Khakoo at 212-639-8292.