Expired Study
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Columbus, Ohio 43210


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Histologically confirmed supratentorial glioblastoma multiforme by stereotactic biopsy, open biopsy, or resection - Maximum diameter of the tumor mass must be no greater than 4 cm in any dimension, including following debulking surgery - Tumor must be at least 1.0 cm from the optic chiasm and brainstem - No oligodendrogliomas, meningiomas, or grade I, II, or III astrocytomas - No infratentorial tumors - No multifocal glioblastoma multiforme - Tumor enhances on MRI - Must have visible tumor on postoperative MRI following surgical resection - Performance status - Karnofsky 60-100% - At least 3 months - Hemoglobin at least 10.0 g/dL - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Bilirubin no greater than 1.5 mg/dL - SGPT no greater than 60 U/L - Creatinine no greater than 1.3 mg/dL - Blood urea nitrogen no greater than 24 mg/dL - Neurological function status 0-3 - No evidence of neuropathy - No glucose-6-phosphate dehydrogenase deficiency - No known history of porphyria - History of prior malignancies allowed - HIV positive status allowed - No medical contraindication to MRI imaging (i.e., pacemaker, aneurysm clip, or nonsecure metal fragment close to a critical structure) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception prior to and during study - At least 6 weeks since prior chemotherapy - Concurrent steroids allowed - No prior radiotherapy to the brain or upper neck - No greater than 5 weeks since prior surgery and recovered


Study is Available At:


Original ID:

NCI-2012-01400


NCT ID:

NCT00004262


Secondary ID:

99H0239


Study Acronym:


Brief Title:

Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme


Official Title:

PHASE I TRIAL OF GADOLINIUM TEXAPHYRIN (PCI -0120) AS A RADIOSENSITIZER DURING STEREOTACTIC RADIOSURGERY BOOST FOR GLIOBLASTOMA MULTIFORME


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Interven


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

12


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:John Grecula
Principal Investigator
Ohio State University

Study Dates

Start Date:November 1999
Primary Completion Date:May 2005
Primary Completion Type:Actual
Verification Date:June 2013
Last Changed Date:June 3, 2013
First Received Date:January 28, 2000

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Time Frame:At the time of stereotactic radiosurgery
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Concentration of gadolinium in tumor, normal brain, and plasma by plasma-atomic emission spectroscopy and liquid chromatography with mass spectrometry
Time Frame:At baseline, at 48 hours, and at 2 weeks post-surgery
Safety Issues:False

Study Interventions

Intervention Type:Procedure
Name:conventional surgery
Arm Name:Treatment (motexafin gadolinium, radiotherapy, rad
Other Name:surgery, conventional
Intervention Type:Radiation
Name:3-dimensional conformal radiation therapy
Arm Name:Treatment (motexafin gadolinium, radiotherapy, rad
Other Name:3D conformal radiation therapy
Intervention Type:Radiation
Name:stereotactic radiosurgery
Arm Name:Treatment (motexafin gadolinium, radiotherapy, rad
Intervention Type:Drug
Name:motexafin gadolinium
Description:Given IV
Arm Name:Treatment (motexafin gadolinium, radiotherapy, rad
Other Name:gadolinium texaphyrin
Intervention Type:Procedure
Name:magnetic resonance imaging
Description:Undergo MRI with both the clinical 1.5 Tesla and research 8 Tesla magnets
Arm Name:Treatment (motexafin gadolinium, radiotherapy, rad
Other Name:MRI
Intervention Type:Procedure
Name:spectroscopy
Description:Undergo plasma-atomic emission spectroscopy (DCP-AES)
Arm Name:Treatment (motexafin gadolinium, radiotherapy, rad

Study Arms

Study Arm Type:Experimental
Arm Name:Treatment (motexafin gadolinium, radiotherapy, radiosurgery)
Description: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.

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Christoforidis GA, Grecula JC, Newton HB, Kangarlu A, Abduljalil AM, Schmalbrock P, Chakeres DW. Visualization of microvascularity in glioblastoma multiforme with 8-T high-spatial-resolution MR imaging. AJNR Am J Neuroradiol. 2002 Oct;23(9):1553-6.
PMID:12372746
Reference Type:Results Reference
Citation:Grecula JC, Grever M, Gupta N, et al.: Phase I trial of motexafin gadolinium (Gd-Tex) during G-knife boost for glioblastoma muliforme. [Abstract] Clin Cancer Res 7: A-762, 3807s, 2001.

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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