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A Phase I/II Study of the Photon Radiosurgery System

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ClinicalTrials.gov Identifier: NCT00179907
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 2, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Brain Tumor, Recurrent Glioblastoma Multiforme Procedure: Photon Radiosurgery System (Intrabeam) Phase 1 Phase 2

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2001
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. To determine the tumor response following reirradiation with PRS. [ Time Frame: End of study ]

Secondary Outcome Measures :
  1. To determine the quality of life of children following irradiation with PRS. [ Time Frame: End of study ]
  2. To study gene expression in tumors before and after irradiation with PRS [ Time Frame: End of study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 32 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00179907


Locations
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
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

Responsible Party: Stewart Goldman, Attending, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT00179907     History of Changes
Other Study ID Numbers: CNS 0201
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: March 2, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Glioblastoma
Brain Neoplasms
Astrocytoma
Glioma
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
Central Nervous System Diseases
Nervous System Diseases