Study of Motexafin Gadolinium With Whole Brain Radiation Therapy Followed by Stereotactic Radiosurgery Boost in the Treatment of Patients With Brain Metastases

Sponsor

Pharmacyclics LLC. (Industry)

Overall Status

Terminated

CT.gov ID

NCT00121420

Collaborator

(none)

Enrollment

Locations

3.8

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasm Metastasis Brain Neoplasms	Drug: Motexafin gadolinium	Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Trial of Motexafin Gadolinium With Whole Brain Radiation Therapy Followed by Stereotactic Radiosurgery Boost in the Treatment of Patients With Brain Metastases

Outcome Measures

Primary Outcome Measures

Rate of irreversible Grade 3 or any Grade 4 or 5 neurologic radiation toxicities occuring within 3 months following SRS boost []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	City	State	Country
1	Phoenix	Arizona	United States
2	Aurora	Colorado	United States
3	Cleveland	Ohio	United States
4	Columbus	Ohio	United States
5	Philadelphia	Pennsylvania	United States
6	Dallas	Texas	United States
7	Houston	Texas	United States
8	Madison	Wisconsin	United States
9	Milwaukee	Wisconsin	United States
10	Montreal	Quebec	Canada
11	Quebec City	Quebec	Canada
12	Sherbrooke	Quebec	Canada