A Phase I/II Study of the Photon Radiosurgery System

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Ann & Robert H Lurie Children's Hospital of Chicago.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Photoelectron Corporation
Information provided by (Responsible Party):
Stewart Goldman, Children's Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00179907
First received: September 12, 2005
Last updated: April 20, 2012
Last verified: April 2012
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

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. [ Time Frame: End of study ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: End of study ] [ Designated as safety issue: Yes ]
  • To determine the tumor response following reirradiation with PRS. [ Time Frame: End of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the quality of life of children following irradiation with PRS. [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • To study gene expression in tumors before and after irradiation with PRS [ Time Frame: End of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: May 2001
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Wendy Stellpfulg, RN 773-880-4373 wastellp@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: Wendy Stellpflug, RN    773-880-4373    wastellp@childrensmemorial.org   
Contact: Stewart Goldman, MD    773-880-4562    SGoldman@childrensmemorial.org   
Sub-Investigator: Stewart Goldman, MD         
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Photoelectron Corporation
Investigators
Principal Investigator: Tadanori Tomita, MD Ann & Robert H Lurie Children's Hospital of Chicago
Principal Investigator: John A. Kalapurakal, MD Northwestern Memorial Hospital
  More Information

No publications provided

Responsible Party: Stewart Goldman, Attending, Children's Memorial Hospital
ClinicalTrials.gov Identifier: NCT00179907     History of Changes
Other Study ID Numbers: CNS 0201
Study First Received: September 12, 2005
Last Updated: April 20, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Glioblastoma
Astrocytoma
Glioma
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 22, 2014