A Phase I/II Study of the Photon Radiosurgery System - Full Text View

Sponsors and Collaborators:	Children's Memorial Hospital Photoelectron Corporation
Information provided by:	Children's Memorial Hospital
ClinicalTrials.gov Identifier:	NCT00179907

Purpose

The standard treatment for children with brain tumors is surgical removal of the tumor followed by radiation to the brain and chemotherapy (medicines) given to shrink any remaining tumor or to prevent tumor from growing back. There are very few treatment options available for children whose brain tumor grows back after receiving radiation treatment. There is a greater risk of complications and side effects when the brain is repeatedly treated with external radiation. The side effects of repeat radiation treatment are dependent on the amount of the brain that is radiated. Radiation given with PRS during surgery is focused to the specific area of the brain where the tumor is located. Therefore, the area of the brain affected by the radiation is smaller. It is hoped that this targeted radiation will lessen the side effects to the normal brain that is not affected by the tumor. It is also hoped that a lower occurrence of side effects will increase the quality of life of children with brain tumors.

The optimal dose of targeted radiation is not known. Therefore, increasing doses will be given to treat different patients, starting with the lowest possible dose. The amount of radiation to be given will depend on whether or not your child received prior radiation therapy and where the tumor is located. The groups of patients will first be divided into 2 groups: Group A, who are those who received radiation as part of their prior treatment, and Group B, who are those who did not receive any radiation treatment. Each group will be then divided again into 2 groups depending on the location of the tumor. In each group, if the lowest dose is well-tolerated with only minimal side effects by 3 patients, then the next higher dose will be given to the next 3 patients.

The purposes of this research are:

To evaluate the potential side effects of a single high dose of x-rays using the Photon Radiosurgery System (PRS) given to a small area of the brain.
To determine the maximum dose of targeted radiation that can be safely given to brain tumors with the fewest side effects.
To see how well this treatment works for children with recurrent brain tumors and newly-diagnosed glioblastoma multiforme.

Condition	Intervention	Phase
Brain Tumor, Recurrent Glioblastoma Multiforme	Procedure: Photon Radiosurgery System (Intrabeam)	Phase I Phase II

MedlinePlus related topics: Brain Cancer Cancer Childhood Brain Tumors

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I/II Study of Reirradiation for Recurrent Pediatric Brain and Spinal Cord Tumors and Primary Glioblastoma Multiforme Using the Photon Radiosurgery System

Further study details as provided by Children's Memorial Hospital:

Primary Outcome Measures:

To determine the maximum tolerated dose of radiation that can be delivered using the Photon Radiosurgery System (PRS) in children with radiation recurrent brain tumors.
To determine the maximum tolerated dose of radiation that can be delivered with a combination of external irradiation and radiosurgery using PRS in children with glioblastoma multiforme and children with recurrent ependymoma
To determine the tumor response following reirradiation with PRS.

Secondary Outcome Measures:

To determine the quality of life of children following irradiation with PRS.
To study gene expression in tumors before and after irradiation with PRS

Estimated Enrollment:	35
Study Start Date:	May 2001

Show Detailed Description

Eligibility

Ages Eligible for Study:	2 Years to 32 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All patients must be between 2 and 32 yrs. of age. Patients who are pregnant or lactating will not be included in this study.
Patients must have an estimated survival time of > 3 months, and a Karnofsky performance status of > 50% or and ECOG performance status of 0-2.
Patient must have radiographic imaging evidence of tumor recurrence except for glioblastoma multiforme.
The recurrent tumor prior to irradiation with PRS must be < 4 cm.
All patients must be > 3 weeks from cytotoxic chemotherapy, except if patient received < 1 week of non-myelotoxic chemotherapy. In that case, patient may be enrolled with permission of the principal investigator.
All patients must be > 6 weeks from high dose chemotherapy with stem cell rescue.
All patients must be > 3 weeks from prior radiation therapy.
Patients with a history of prior irradiation will be included.
Informed consent must be obtained prior to registration on the study.

Tumor Sites:

Brain
Spinal Cord

Tumor Types:

Recurrent Medulloblastoma
Recurrent Ependymoma (recurrence regardless of primary treatment)
Recurrent Glioma
Glioblastoma Multiforme
Recurrent Craniopharyngioma
Recurrent PNET (Primitive Neuroectodermal tumor)
Recurrent Meningioma
Recurrent Pineoblastoma

Tumor Size:

< 4 cm in maximum diameter

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179907

Contacts

Contact: Carrie Kempler, MS	773-883-6186	ckempler@childrensmemorial.org
Contact: Stewart Goldman, MD	773-880-4562	SGoldman@childrensmemorial.org

Locations

United States, Illinois
Children's Memorial Hospital	Recruiting
Chicago, Illinois, United States, 60614
Contact: Carrie Kempler, MS 773-883-6186 ckempler@childrensmemorial.org
Contact: Stewart Goldman, MD 773-880-4562 SGoldman@childrensmemorial.org
Sub-Investigator: Stewart Goldman, MD

Sponsors and Collaborators

Children's Memorial Hospital

Photoelectron Corporation

Investigators

Principal Investigator:	Tadanori Tomita, MD	Children's Memorial Hospital
Principal Investigator:	John A. Kalapurakal, MD	Northwestern Memorial Hospital

More Information

Study ID Numbers:	CNS 0201
Study First Received:	September 12, 2005
Last Updated:	January 31, 2008
ClinicalTrials.gov Identifier:	NCT00179907
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Glioblastoma
Spinal cord neoplasm
Astrocytoma
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Recurrence
Brain Neoplasms

Neuroectodermal Tumors
Glioblastoma multiforme
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Spinal Cord Neoplasms
Glioma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Disease Attributes
Neoplasms
Pathologic Processes
Neoplasms by Histologic Type

Neoplasms by Site
Neoplasms, Nerve Tissue
Nervous System Diseases
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on January 14, 2009