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

Adult Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004262
• Other study ID #: NCI-2012-01400
• Secondary ID: 99H0239CDR000006
• Status: Completed
• Phase: Phase 1
• First received: January 28, 2000
• Last updated: June 3, 2013
• Start date: November 1999

Study information

• Verified date: June 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adult Giant Cell Glioblastoma
• Adult Glioblastoma
• Adult Gliosarcoma
• Glioblastoma
• Gliosarcoma

Intervention

Procedure:
• conventional surgery

Radiation:
• 3-dimensional conformal radiation therapy

• stereotactic radiosurgery

Drug:
• motexafin gadolinium
Given IV

Procedure:
• magnetic resonance imaging
Undergo MRI with both the clinical 1.5 Tesla and research 8 Tesla magnets
• spectroscopy
Undergo plasma-atomic emission spectroscopy (DCP-AES)

Locations

Country	Name	City	State
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No