Phase II Trial of Motexafin Gadolinium With Whole Brain Radiation Therapy Followed by Stereotactic Radiosurgery Boost in the Treatment of Patients With Brain Metastases
18 Years
N/A
Both
Neoplasm Metastasis, Brain Neoplasms
Trial Information
Phase II Trial of Motexafin Gadolinium With Whole Brain Radiation Therapy Followed by Stereotactic Radiosurgery Boost in the Treatment of Patients With Brain Metastases
Patients will receive three weeks of whole brain radiation therapy concurrent with daily
motexafin gadolinium during weeks 2 and 3, followed by a stereotactic radiosurgery boost
concurrent with motexafin gadolinium. Patients will be followed for radiologic response,
neurologic progression, and neurocognitive progression.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Rate of irreversible Grade 3 or any Grade 4 or 5 neurologic radiation toxicities occurring within 3 months following SRS boost.
Principal Investigator
Minesh P Mehta, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Wisconsin, Madison
Authority:
United States: Food and Drug Administration
Study ID:
PCYC-0224
NCT ID:
NCT00121420
Start Date:
Completion Date:
Related Keywords:
- Neoplasm Metastasis
- Brain Neoplasms
- Brain Neoplasms/secondary
- Brain neoplasms/radiotherapy
- Brain metastasis
- Neoplasm metastasis
- Cranial irradiation
- Radiosurgery
- Lung Neoplasms
- Breast Neoplasms
- Kidney Neoplasms
- Melanoma
- Radiotherapy
- Carcinoma, non-small cell lung
- Brain Neoplasms
- Neoplasms
- Neoplasm Metastasis
- Neoplasms, Second Primary
Name | Location |
|---|---|
| Phoenix, Arizona 85012 | |
| Cleveland, Ohio 44195 | |
| Philadelphia, Pennsylvania 19104 | |
| Austin, Texas 78705 | |
| Denver, Colorado | |
| Milwaukee, Wisconsin |
