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


Phase 2
18 Years
N/A
Not Enrolling
Both
Neoplasm Metastasis, Brain Neoplasms

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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