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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00121420

Enrollment

Registered

2005-07-21

Start date

Unknown

Completion date

Unknown

Last updated

2014-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Neoplasms, Neoplasm Metastasis

Keywords

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

Brief summary

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.

Detailed description

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.

Interventions

DRUGMotexafin gadolinium

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Rate of irreversible Grade 3 or any Grade 4 or 5 neurologic radiation toxicities occuring within 3 months following SRS boost	—

Secondary

Measure	Time frame
Change in lesion size and number between screening MRI and SRS treatment -planning MRI	—
Time to neuroligic progression or death with evidence of neurologic progression	—
Time to neurocognitive progression	—

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026