Study of Neurologic Progression With Motexafin Gadolinium and Radiation Therapy (SMART)

This study has been completed.

First Received on February 10, 2003. Last Updated on May 4, 2007 History of Changes

Sponsor:	Pharmacyclics
Information provided by:	Pharmacyclics
ClinicalTrials.gov Identifier:	NCT00054795

Purpose

The primary purpose of the study is to determine if patients with brain metastases from non-small cell lung cancer treated with Motexafin Gadolinium and whole brain radiation therapy retain their neurologic function and ability to think for a longer time compared to patients treated with whole brain radiation therapy alone.

Condition	Intervention	Phase
Brain Neoplasms Carcinoma, Non-Small-Cell Lung Metastases, Neoplasm	Drug: Motexafin Gadolinium	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized Phase III Trial of Xcytrin® (Motexafin Gadolinium) Injection for the Treatment of Brain Metastases in Patients With Non-Small Cell Lung Cancer Undergoing Whole Brain Radiation Therapy

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer Lung Cancer

Drug Information available for: Motexafin gadolinium Motexafin

U.S. FDA Resources

Further study details as provided by Pharmacyclics:

Estimated Enrollment:

550

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adults (≥18 years old) with radiologically proven parenchymal brain metastases from histologically confirmed non-small cell lung cancer;
KPS score of ≥70;
Each patient must sign a study-specific Informed Consent form

Exclusion Criteria:

Liver metastases;
Extracranial metastases in two or more organs;
Known leptomeningeal metastases or subarachnoid spread of tumor;
Prior whole brain radiation;
Plan to use radiosurgery or radiation boost after completion of WBRT;
Planned chemotherapy during study treatment (prior and subsequent chemotherapy is allowed);
Prior total resection of a single brain metastasis;
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 > 2 x ULN; Total bilirubin > 2 x ULN;

Women who are pregnant or lactating

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054795

Show 92 Study Locations

Sponsors and Collaborators

Pharmacyclics

More Information

Additional Information:

National Brain Tumor Foundation This link exits the ClinicalTrials.gov site

Publications:

Mehta MP, Shapiro WR, Glantz MJ, Patchell RA, Weitzner MA, Meyers CA, Schultz CJ, Roa WH, Leibenhaut M, Ford J, Curran W, Phan S, Smith JA, Miller RA, Renschler MF. Lead-in phase to randomized trial of motexafin gadolinium and whole-brain radiation for patients with brain metastases: centralized assessment of magnetic resonance imaging, neurocognitive, and neurologic end points. J Clin Oncol. 2002 Aug 15;20(16):3445-53.

Carde P, Timmerman R, Mehta MP, Koprowski CD, Ford J, Tishler RB, Miles D, Miller RA, Renschler MF. Multicenter phase Ib/II trial of the radiation enhancer motexafin gadolinium in patients with brain metastases. J Clin Oncol. 2001 Apr 1;19(7):2074-83.

Rosenthal DI, Nurenberg P, Becerra CR, Frenkel EP, Carbone DP, Lum BL, Miller R, Engel J, Young S, Miles D, Renschler MF. A phase I single-dose trial of gadolinium texaphyrin (Gd-Tex), a tumor selective radiation sensitizer detectable by magnetic resonance imaging. Clin Cancer Res. 1999 Apr;5(4):739-45.

Magda D, Lepp C, Gerasimchuk N, Lee I, Sessler JL, Lin A, Biaglow JE, Miller RA. Redox cycling by motexafin gadolinium enhances cellular response to ionizing radiation by forming reactive oxygen species. Int J Radiat Oncol Biol Phys. 2001 Nov 15;51(4):1025-36.

Miller RA, Woodburn K, Fan Q, Renschler MF, Sessler JL, Koutcher JA. In vivo animal studies with gadolinium (III) texaphyrin as a radiation enhancer. Int J Radiat Oncol Biol Phys. 1999 Nov 1;45(4):981-9.

ClinicalTrials.gov Identifier:	NCT00054795 History of Changes
Obsolete Identifiers:	NCT00066820
Other Study ID Numbers:	PCYC-0211
Study First Received:	February 10, 2003
Last Updated:	May 4, 2007
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pharmacyclics:

Brain Neoplasms/radiotherapy
Neoplasms/complications/prevention & control,
Neuropsychological Tests,
Metalloporphyrins/therapeutic use,
Combined Modality Therapy,
Drug therapy,
Quality of Life,
Cranial Irradiation,

Radiotherapy/Targeted,
Prospective Studies,
Neoplasm Recurrence/Local,
Treatment Outcome
Brain metastases
Brain Neoplasms/secondary
Non-small cell lung cancer

Additional relevant MeSH terms:

Brain Neoplasms
Neoplasms
Carcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms

Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Motexafin gadolinium
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Dermatologic Agents

ClinicalTrials.gov processed this record on February 12, 2012