Overview
Motexafin Gadolinium With MRI-Guided Surgery in Treating Patients With High-Grade Gliomas
Status:
Completed
Completed
Trial end date:
2004-06-01
2004-06-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
RATIONALE: New imaging procedures such as the use of gadolinium texaphyrin with MRI may improve the ability to detect the extent of gliomas. PURPOSE: Phase I trial to study the effectiveness of gadolinium texaphyrin used with MRI-guided surgery in treating patients with high-grade glioma.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Jonsson Comprehensive Cancer CenterCollaborator:
National Cancer Institute (NCI)Treatments:
Motexafin gadolinium
Criteria
DISEASE CHARACTERISTICS: Radiological diagnosis of probable high grade glioma, or biopsyproven high grade glioma, undergoing neurosurgery (biopsy or tumor resection) with
interactive MRI guided control Must have an enhancing cerebral lesion No radiological
diagnosis of metastases due to multiple lesions
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% while on
steroids Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Granulocyte
count at least 1,500/mm3 Platelet count at least 100,000/mm3 Prothrombin time no greater
than 1.5 times upper limit of normal (ULN) Active partial thromboplastin time no greater
than 1.5 times ULN Hepatic: Bilirubin no greater than 2 mg/dL AST and ALT no greater than 2
times ULN Renal: Creatinine less than 1.5 mg/dL Cardiovascular: No severe cardiac disease
Pulmonary: No severe pulmonary disease Other: No other significant life threatening disease
No known glucose-6-phosphate dehydrogenase deficiency or porphyria No other active
malignancy No intractable seizures Not pregnant or nursing Effective contraception required
of all fertile patients
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: Concurrent steroids allowed Radiotherapy: Concurrent radiotherapy
allowed Surgery: See Disease Characteristics Other: At least 48 hours since prior MRI scan
with contrast No concurrent active agent or investigational drug No concurrent use of other
study treatment Concurrent antiseizure medication allowed