We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00054795
First Posted: February 13, 2003
Last Update Posted: May 8, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pharmacyclics LLC.
  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
Intervention Model: Parallel Assignment
Masking: None (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 LLC.:

Estimated Enrollment: 550
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00054795


  Show 92 Study Locations
Sponsors and Collaborators
Pharmacyclics LLC.
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00054795     History of Changes
Obsolete Identifiers: NCT00066820
Other Study ID Numbers: PCYC-0211
First Submitted: February 10, 2003
First Posted: February 13, 2003
Last Update Posted: May 8, 2007
Last Verified: May 2007

Keywords provided by Pharmacyclics LLC.:
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:
Neoplasms
Neoplasm Metastasis
Carcinoma, Non-Small-Cell Lung
Brain Neoplasms
Neoplastic Processes
Pathologic Processes
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Motexafin gadolinium
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents