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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. completion date
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


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
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