CNS1123: Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors

Phase II Trial of Response-Based Radiation Therapy for Patients with Localized Central Nervous System Germ Cell Tumors (CNS GCT)

Categories:

Brain Tumor

Phase I/II

Diseases Treated:

Newly diagnosed localize primary NGGCT or newly diagnosed localized germinoma

Eligibility Overview:

  • Participant is > 3 years and < 21 years at the time of enrollment.
  • Participant has newly diagnosed localized primary NGGCT or newly diagnosed localized germinoma (has not spread to other parts of the brain or spine).
  • Participant must have adequate bone marrow function.
  • Participant must have normal renal and liver function for age.
  • NO prior therapy except surgery and/or steroids.

Description

A germinoma germ cell tumor can be malignant (cancerous) and can sometimes spread though the brain and spinal canal before symptoms appear. There are different types of germ cell tumors. Doctors find out which type a person has based on the results of a biopsy and/or tumor markers. A biopsy is a surgical procedure that removes a portion of the tumor for testing. Tumor markers are found by testing for chemical substances (such as proteins) that are produced by tumor cells and released into the body fluids.

Non-germinomatous germ cell tumor (NGGCT) is a type of brain cancer. This tumor is sometimes localized. The term localized means that the tumor has not spread to other parts of the brain or the body. A NGGCT can be malignant (cancerous) and can sometimes spread through the brain and the spinal canal before symptoms appear.

Objectives

  • To find out if using a lower dose of radiation after chemotherapy in participants whose disease responds well to chemotherapy will work as well as using the standard dose of radiation to get rid of the newly diagnosed germinoma for as long as possible.
  • To learn about the neuropsychological (for example, thinking, learning, and remembering) and behavioral functioning of children and young adults being treated for newly diagnosed localized germinoma or NGGCT

Eligibility Criteria, among others, include:

  • Participant is > 3 years and <  21years at the time of enrollment.
  • Participant has newly diagnosed localized primary NGGCT or newly diagnosed localized germinoma.(has not spread to other parts of the brain or spine).
  • Must be enrolled within 31 days from definitive surgery or clinical diagnosis.
  • Participant must have adequate bone marrow function.
  • Participant must have normal renal and liver function for age.
  • NO prior therapy except surgery and/or steroids.
  • Must agree to also be enrolled on ALTE07C1 protocol to enroll on this study.

Contact

Ibrahim Qaddoumi, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Phone: 901-595-2544 or 901-595-4599
Fax: 901-595-6211

OR

Tabatha E. Doyle, RN
Coordinator, Brain Tumor Program
MS 260
262 Danny Thomas Place
Memphis, TN 38105
Phone: (901) 595-2544
FAX: (901) 595-6211

Referring or consulting clinicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.