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| ID | Type | Description | Link |
|---|---|---|---|
| 99H0239 | |||
| CDR0000067517 | |||
| NCI-T99-0041 | |||
| OSU-9976 | |||
| OSU-99H0239 | |||
| U01CA076576 | U.S. NIH Grant/Contract | View source |
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Phase I trial to study the effectiveness of radiation therapy and gadolinium texaphyrin in treating patients who have supratentorial glioblastoma multiforme. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as gadolinium texaphyrin may make the tumor cells more sensitive to radiation therapy.
PRIMARY OBJECTIVES:
I. Determine the frequency and grade of toxicity of gadolinium texaphyrin as a radiosensitizer at two dose levels in patients with supratentorial glioblastoma multiforme undergoing stereotactic radiosurgery.
II. Compare the tumor, normal brain, and plasma concentrations of this drug regimen to 1.5 and 8 Tesla MRI images in this patient population.
III. Determine if the 8 Tesla images provide more data than the 1.5 Tesla images in terms of the radiosensitizing drug distribution in the tumor in these patients.
OUTLINE: This is a dose escalation study.
Within 5 weeks following surgery, patients receive daily external beam radiotherapy five days a week for 5 weeks. Within 2 weeks following completion of radiotherapy, patients receive gadolinium texaphyrin IV over 2 hours followed 3 hours later by stereotactic radiosurgery. Patients undergoing surgical debulking of tumor prior to external beam radiotherapy receive gadolinium texaphyrin IV over 2 hours, 3 hours prior to surgery in addition to the dose prior to stereotactic radiosurgery.
Cohorts of 3-6 patients receive escalating doses of gadolinium texaphyrin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.
Patients are followed monthly for 3 months, and then every 3 months for 5 years or until death.
PROJECTED ACCRUAL: Approximately 12-18 patients will be accrued for this study within 12-18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (motexafin gadolinium, radiotherapy, radiosurgery) | Experimental | Within 5 weeks following surgery, patients receive daily external beam radiotherapy five days a week for 5 weeks. Within 2 weeks following completion of radiotherapy, patients receive gadolinium texaphyrin IV over 2 hours followed 3 hours later by stereotactic radiosurgery. Patients undergoing surgical debulking of tumor prior to external beam radiotherapy receive gadolinium texaphyrin IV over 2 hours, 3 hours prior to surgery in addition to the dose prior to stereotactic radiosurgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conventional surgery | Procedure |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum-tolerated dose (MTD) based on the incidence of dose-limiting toxicity (DLT), as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 2.0 | At the time of stereotactic radiosurgery |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of gadolinium in tumor, normal brain, and plasma by plasma-atomic emission spectroscopy and liquid chromatography with mass spectrometry | At baseline, at 48 hours, and at 2 weeks post-surgery |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Grecula | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
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| 3-dimensional conformal radiation therapy | Radiation |
|
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| stereotactic radiosurgery | Radiation |
|
| motexafin gadolinium | Drug | Given IV |
|
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| magnetic resonance imaging | Procedure | Undergo MRI with both the clinical 1.5 Tesla and research 8 Tesla magnets |
|
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| spectroscopy | Procedure | Undergo plasma-atomic emission spectroscopy (DCP-AES) |
|
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D018316 | Gliosarcoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D003226 | Congresses as Topic |
| D020266 | Radiotherapy, Conformal |
| D016634 | Radiosurgery |
| C437683 | motexafin gadolinium |
| D009682 | Magnetic Resonance Spectroscopy |
| D013057 | Spectrum Analysis |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D008919 | Investigative Techniques |
| D002623 | Chemistry Techniques, Analytical |
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