Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme
Completed · Phase 1
Conditions studied: Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma
In brief
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.
Key facts
- Study ID
- NCT00004262
- Run by
- National Cancer Institute (NCI)
- People needed
- 12
- Starts
- 1999-11-01
- Last updated by the study team
- 2013-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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