Clinical trial · Interventional
Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme
PHASE I TRIAL OF GADOLINIUM TEXAPHYRIN (PCI -0120) AS A RADIOSENSITIZER DURING STEREOTACTIC RADIOSURGERY BOOST FOR GLIOBLASTOMA MULTIFORME
NCT00004262CI-TRIAL-00010581completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Giant Cell Glioblastoma | Adult Giant Cell Glioblastoma | ONTOLOGY_EXACT | 0.98 |
| Adult Glioblastoma | Adult Glioblastoma | ONTOLOGY_EXACT | 0.98 |
| Adult Gliosarcoma | Adult Gliosarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-dimensional conformal radiation therapy | Radiation | — | UNRESOLVED |
| conventional surgery | Procedure | — | UNRESOLVED |
| magnetic resonance imaging | Procedure | — | UNRESOLVED |
| motexafin gadolinium | Drug | — | UNRESOLVED |
| spectroscopy | Procedure | — | UNRESOLVED |
| stereotactic radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 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.
- interventionNames
- Procedure: conventional surgery
- Radiation: 3-dimensional conformal radiation therapy
- Radiation: stereotactic radiosurgery
- Drug: motexafin gadolinium
- Procedure: magnetic resonance imaging
- Procedure: spectroscopy
Primary outcomes (1)
- 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
- timeFrame
- At the time of stereotactic radiosurgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.