Clinical trial · Interventional
Study of Motexafin Gadolinium With Whole Brain Radiation Therapy Followed by Stereotactic Radiosurgery Boost in the Treatment of Patients With Brain Metastases
Phase II Trial of Motexafin Gadolinium With Whole Brain Radiation Therapy Followed by Stereotactic Radiosurgery Boost in the Treatment of Patients With Brain Metastases
NCT00121420CI-TRIAL-00014469terminatedPhase 2ClinicalTrials.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)
The primary purpose of the study is to evaluate if motexafin gadolinium with whole brain radiation therapy followed by a stereotactic radiosurgery boost is a safe and effective treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Neoplasms | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Motexafin gadolinium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Rate of irreversible Grade 3 or any Grade 4 or 5 neurologic radiation toxicities occuring within 3 months following SRS boost
Secondary outcomes (3)
- measure
- Change in lesion size and number between screening MRI and SRS treatment -planning MRI
- measure
- Time to neuroligic progression or death with evidence of neurologic progression
- measure
- Time to neurocognitive progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Karnofsky performance status (KPS) ≥ 70 * Histologically confirmed malignancy with the presence of one to four intraparenchymal brain metastases * Each patient must sign a study-specific Informed Consent form Exclusion Criteria: * Previous cranial radiation * Complete resection of all known brain metastases * Known leptomeningeal metastases * Known liver metastases * Clinical or radiologic evidence of progression (other than study lesion\[s) within 1 month prior to enrollment * Patients with metastases within 10 mm of the optic apparatus * Patients with metastases in the brainstem, midbrain, pons, or medulla * Planned chemotherapy during WBRT and/or SRS * Uncontrolled hypertension * Women who are pregnant or lactating and Laboratory values as follows: * LDH \> 1.3 x upper limit of normal (ULN) * ANC \< 1500/mm3 * Platelets \< 50,000/mm3 * Creatinine \> 2.0 mg/dL * AST or ALT \> 3 x ULN * Total bilirubin \> 2 x ULN
References
Publications (5)
- BACKGROUNDMehta MP, Rodrigus P, Terhaard CH, Rao A, Suh J, Roa W, Souhami L, Bezjak A, Leibenhaut M, Komaki R, Schultz C, Timmerman R, Curran W, Smith J, Phan SC, Miller RA, Renschler MF. Survival and neurologic outcomes in a randomized trial of motexafin gadolinium and whole-brain radiation therapy in brain metastases. J Clin Oncol. 2003 Jul 1;21(13):2529-36. doi: 10.1200/JCO.2003.12.122. PMID 12829672
- BACKGROUNDEvens AM. Motexafin gadolinium: a redox-active tumor selective agent for the treatment of cancer. Curr Opin Oncol. 2004 Nov;16(6):576-80. doi: 10.1097/01.cco.0000142073.29850.98. PMID 15627019
- BACKGROUNDBiaglow JE, Miller RA. The thioredoxin reductase/thioredoxin system: novel redox targets for cancer therapy. Cancer Biol Ther. 2005 Jan;4(1):6-13. doi: 10.4161/cbt.4.1.1434. Epub 2004 Jan 8. PMID 15684606
- BACKGROUNDManon R, Hui S, Chinnaiyan P, Suh J, Chang E, Timmerman R, Phan S, Das R, Mehta M. The impact of mid-treatment MRI on defining boost volumes in the radiation treatment of glioblastoma multiforme. Technol Cancer Res Treat. 2004 Jun;3(3):303-7. doi: 10.1177/153303460400300308. PMID 15161323
- BACKGROUNDMeyers CA, Smith JA, Bezjak A, Mehta MP, Liebmann J, Illidge T, Kunkler I, Caudrelier JM, Eisenberg PD, Meerwaldt J, Siemers R, Carrie C, Gaspar LE, Curran W, Phan SC, Miller RA, Renschler MF. Neurocognitive function and progression in patients with brain metastases treated with whole-brain radiation and motexafin gadolinium: results of a randomized phase III trial. J Clin Oncol. 2004 Jan 1;22(1):157-65. doi: 10.1200/JCO.2004.05.128. PMID 14701778