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Home > "T" Clinical Trials Conditions > Temozolomide for Treatment of Brain Metastases from Non-Small Cell Lung Cancer

Temozolomide for Treatment of Brain Metastases from Non-Small Cell Lung Cancer



Temozolomide for Treatment of Brain Metastases from Non-Small Cell Lung Cancer

For Condition: Carcinoma, Non-Small-Cell Lung,Neoplasm Metastasis,Brain Neoplasms
Status: Recruiting
Sponsor(s): Schering-Plough ,
Synopsis: The purpose of this study is to demonstrate improvement in overall survival for the combination of whole brain radiation therapy (WBRT) plus temozolomide (TMZ) vs WBRT plus placebo. Secondary objective is to demonstrate an improvement in the time to radiological CNS progression with the addition of TMZ to WBRT.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: - Age greater than or equal to 18 - Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC) - At least one brain metastasis diagnosed within 30 days of randomization - Brain metastases must not have been previously treated with WBRT or radiosurgery - No more than 2 sites of extracranial metastases - May have received prior radiation therapy to the primary tumor and/or systemic metastatic sites - Meets protocol requirements for specified laboratory values. - Written informed consent and cooperation of patient - Appropriate use of effective contraception if of childbearing potential. - Karnofsky Performance Status KPS greater than 70 - Score less than 2 on all criteria of the Comprehensive Neutrological Outcome Scale (CNOS)
Total Enrollment: 550

Location and Contact Information:

Eastern CT Hem/Onc Associates *Not yet recruiting*
Norwich,  Connecticut,  06360
United States
Not yet recruiting Dennis  Slater 860-886-8362

Dent Neurologic Institute *Recruiting*
Buffalo,  New York, 
United States
Recruiting Laszio  Mechtler 716-877-5127

Memorial Sloan Kettering Cancer *Recruiting*
New York City,  New York, 
United States
Recruiting Lauren  Abrey 646-227-2908

Southern Oncology Research *Recruiting*
Greenville,  North Carolina,  27834
United States
Recruiting Jesse  Lee 252-413-6628

Cleveland Clinic Foundation *Not yet recruiting*
Cleveland,  Ohio,  44195
United States
Not yet recruiting John  Suh 216-444-5574

Radiation Oncology Department *Recruiting*
Tucson,  Arizona,  85724
United States
Recruiting Baldasarre  Stea 520-626-6800

New York Presbyterian Hospital *Recruiting*
New York City,  New York, 
United States
Recruiting Susan  Pannullo 212-746-2076

DeQuatto Community Cancer Center *Not yet recruiting*
Manchester,  Connecticut,  06040
United States
Not yet recruiting Jeffrey  Wasser 860-646-0670

The Queen's Medical Center *Recruiting*
Honolulu,  Hawaii,  96813
United States
Recruiting Kaye  Kawahara 808-537-7574

Central Baptist Hospital *Recruiting*
Lexington,  Kentucky,  40503
United States
Recruiting Lee  Hicks 859-276-0414

Carolina NeuroSurgery & Spine Associates *Recruiting*
Charlotte,  North Carolina,  28207
United States
Recruiting Benjamin  Ramis 704-371-6492

Dent Neurologic Institute *Recruiting*
Amherst,  New York,  14226
United States
Recruiting Laszio  Mechtler 716-250-2028

MD Anderson Cancer Center *Recruiting*
Orlando,  Florida,  32806
United States
Recruiting Jennifer  Tseng 321-841-1859

Metro-Minnesota Community Clinical Oncology Program *Not yet recruiting*
Minneapolis,  Minnesota,  55426
United States
Not yet recruiting Timothy  Larson 952-993-1545

University Hospitals of Cleveland *Recruiting*
Cleveland,  Ohio,  44106
United States
Recruiting Afshin  Dowlati 216-844-1637

Queen's Medical Hospital *Recruiting*
Honolulu,  Hawaii, 
United States
Recruiting Kaye  Kawahara 808-537-7574

Cancer Specialists of South Texas *Recruiting*
Corpus Christi,  Texas,  78411
United States
Recruiting Alice  Chen 361-993-3456

Dana-Farber Cancer Institute *Recruiting*
Boston,  Massachusetts,  02115
United States
Recruiting Patrick  Wen 617-632-3780

Prebyterian Hospital Center for Cancer Research *Recruiting*
Charlotte,  North Carolina,  28233
United States
Recruiting Richard  Reiling 704-384-8920

Thomas Jefferson University Hospital *Recruiting*
Philadelphia,  Pennsylvania,  19107
United States
Recruiting Walter  Curran 215-503-5641

Overlake Medical Hospital *Recruiting*
Bellevue,  Washington, 
United States
Recruiting John  Rieke 425-688-5407

Cedars Sinai Cancer Center *Recruiting*
Los Angeles,  California,  90048
United States
Recruiting Ronald  Natale 310-423-0721

Bethesda Memorial Hospital *Recruiting*
Boynton Beach,  Florida,  33435
United States
Recruiting Roger  Brito 561-374-5020

Medical Oncology Associations of Augusta *Recruiting*
Augusta,  Georgia,  30901
United States
Recruiting Shlaer  Stephen 706-722-4245

Kellogg Cancer Care Center/Evanston Hospital *Not yet recruiting*
Evanston,  Illinois,  60201
United States
Not yet recruiting Nina  Paleologos 847-570-2025

Odyssey Research *Recruiting*
Bismark,  North Dakota,  58501
United States
Recruiting Thomas  Wos 701-250-7355

Odyssey Research *Recruiting*
Bismark,  North Dakota, 
United States
Recruiting M  Thomas 701-250-7355

Baptist Regional Hospital Cancer Center *Recruiting*
Knoxville,  Tennessee,  37920
United States
Recruiting Tracy  Dobbs 865-549-4107

James Brown Cancer Center *Recruiting*
Louisville,  Kentucky,  40202
United States
Recruiting Donald  Miller 502-562-4585

Cancer Specialists of South Texas *Recruiting*
Corpus Christi,  Texas, 
United States
Recruiting Alice  Chen 361-993-3456

Overlake Hospital Medical Center *Recruiting*
Bellevue,  Washington,  98004
United States
Recruiting John  Rieke 425-688-5407

St. Luke's Mountain State Tumor *Recruiting*
Boise,  Idaho,  83712
United States
Recruiting Theodore  Walters 208-381-3132

Mayo Clinic *Recruiting*
Jacksonville,  Florida,  32224
United States
Recruiting Kurt  Jaeckle 904-953-7645

Hematology Oncology of Indiana *Recruiting*
Indianapolis,  Indiana,  46260
United States
Recruiting Ruemu  Birhiray 317-415-6631

University of Pittsburg Cancer Institute *Not yet recruiting*
Pittsburgh,  Pennsylvania,  15232
United States
Not yet recruiting Chandra  Belani 412-648-6619

Christus St. Francis Cabrini Medical Center *Not yet recruiting*
Alexandria,  Louisiana,  71301
United States
Not yet recruiting Paul  Zhang 318-448-6917

Sharp Memorial Hospital *Recruiting*
San Diego,  California,  92123
United States
Recruiting David  Bodkin 858-939-5061

H. Lee Moffitt Cancer Center & Research Institute *Recruiting*
Tampa,  Florida,  33612
United States
Recruiting Susan  Snodgrass 813-972-8332

Emory University - Winship Cancer Center *Recruiting*
Atlanta,  Georgia,  30322
United States
Recruiting Michael  Fanucchi 404-778-5959

Greenville CCOP Cancer Center *Recruiting*
Greenville,  South Carolina,  29615
United States
Recruiting Jeffrey  Giguere 864-241-6251


Additional Information:
Study ID Numbers:
  P03247; 
Study Start Date: December 2003
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00076856

Other Carcinoma, Non-Small-Cell Lung Studies:
1. A Phase I Study of the Combination of Continuous Daily CAI and Intermittent Paclitaxel in Adult Patients with Refractory Cancers or Lymphoma

2. Stem Cell Transplant for Malignant Melanoma

3. A Phase I Study of Oral COL-3 (NSC-683551), a Matrix Metalloproteinase Inhibitor, in Patients with Refractory Metastatic Cancer

4. Temozolomide for Treatment of Brain Metastases from Non-Small Cell Lung Cancer

5. A Phase I Study of Infusional Chemotherapy with the P-Glycoprotein Antagonist PSC 833

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Temozolomide for Treatment of Brain Metastases from Non-Small Cell Lung Cancer

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