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

Neoplasm Metastasis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00121420
• Other study ID #: PCYC-0224
• Status: Terminated
• Phase: Phase 2
• First received: July 14, 2005
• Last updated: May 7, 2014

Study information

• Verified date: May 2014
• Source: Pharmacyclics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Neoplasms
• Neoplasm Metastasis
• Neoplasms

Intervention

Drug:
• Motexafin gadolinium

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacyclics

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (5)

Biaglow JE, Miller RA. The thioredoxin reductase/thioredoxin system: novel redox targets for cancer therapy. Cancer Biol Ther. 2005 Jan;4(1):6-13. Epub 2004 Jan 8. Review. — View Citation

Evens AM. Motexafin gadolinium: a redox-active tumor selective agent for the treatment of cancer. Curr Opin Oncol. 2004 Nov;16(6):576-80. Review. — View Citation

Manon 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. — View Citation

Mehta 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. — View Citation

Meyers 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of irreversible Grade 3 or any Grade 4 or 5 neurologic radiation toxicities occuring within 3 months following SRS boost
Secondary	Change in lesion size and number between screening MRI and SRS treatment -planning MRI
Secondary	Time to neuroligic progression or death with evidence of neurologic progression
Secondary	Time to neurocognitive progression

External Links

•   National Brain Tumor Foundation
•   Pharmacyclics