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A Phase I/II Study of the Photon Radiosurgery System

NCT00179907 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2015-03-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

Photon Radiosurgery System (Intrabeam)

In this study we had intended to perform a similar dose escalation study with doses ranging from 10-19 Gy, 10-16 Gy and 10 - 14 Gy for tumors \< 20 mm, 21-25 mm and 26-40 mm respectively

Sponsors & Collaborators

  • Photoelectron Corporation

    collaborator UNKNOWN

  • Ann & Robert H Lurie Children's Hospital of Chicago

    lead OTHER

Principal Investigators

  • Tadanori Tomita, MD · Ann & Robert H Lurie Children's Hospital of Chicago

  • John A. Kalapurakal, MD · Northwestern Memorial Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
32 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-05-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00179907 on ClinicalTrials.gov