A Phase I/II Study of the Photon Radiosurgery System
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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 |
- 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 ]
- 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) |
-
Procedure: Photon Radiosurgery System (Intrabeam)
Show Detailed Description Eligibility| Ages Eligible for Study: | 2 Years to 32 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Wendy Stellpfulg, RN | 773-880-4373 | wastellp@childrensmemorial.org |
| Contact: Stewart Goldman, MD | 773-880-4562 | SGoldman@childrensmemorial.org |
| 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 | |
| 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 Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Glioblastoma Central Nervous System Diseases Nervous System Diseases Astrocytoma Glioma |
ClinicalTrials.gov processed this record on June 18, 2013