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

This study has been completed.
Sponsor:
Information provided by:
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT00054795
First received: February 10, 2003
Last updated: May 4, 2007
Last verified: May 2007
  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 3

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 92 Study Locations
Sponsors and Collaborators
Pharmacyclics
  More Information

Additional Information:
Publications:
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
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Neoplasms
Brain Diseases
Bronchial Neoplasms
Carcinoma, Bronchogenic
Central Nervous System Diseases
Central Nervous System Neoplasms
Lung Diseases
Lung Neoplasms
Neoplasms by Site
Neoplastic Processes
Nervous System Diseases
Nervous System Neoplasms
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Motexafin gadolinium
Antineoplastic Agents
Contrast Media
Dermatologic Agents
Diagnostic Uses of Chemicals
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014