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Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases Clinical research trials and Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases. Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases clinical trial. Test subjects typically receive the most effective healthcare possible for their Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases  Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases
Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases
For Condition: brain metastases
Status: No longer recruiting
Sponsor(s): Allos Therapeutics ,
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as RSR13 may make tumor cells more sensitive to radiation therapy. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the brain with or without RSR13 in treating patients who have brain metastases.
Details: OBJECTIVES: I. Compare the median survival time in patients with brain metastases after receiving treatment with whole brain radiotherapy with or without RSR13. II. Compare the response rate to these treatment regimens in these patients. III. Compare the time to progression after receiving these treatment regimens in these patients. IV. Compare quality of life in these patients receiving these treatment regimens. V. Compare cause of death (neurologic vs nonneurologic death) in these patients after receiving these treatment regimens. VI. Determine the safety of RSR13 in these patients. VII. Assess the pharmacokinetics of RSR13 in these patients. PROTOCOL OUTLINE: This is a randomized, open label, comparative, multicenter study. Patients are stratified according to the Radiation Therapy Oncology Group RPA Class (I vs II). Patients are further stratified within the RPA class II stratum according to site of primary cancer (non-small cell lung cancer vs breast vs other). Patients are randomized to one of two treatment arms. Arm I: Patients receive whole brain radiotherapy 5 days a week for two weeks in conjunction with supplemental oxygen breathing. Arm II: Patients receive RSR13 IV over 30 minutes followed by whole brain radiotherapy and supplemental oxygen breathing as in arm I. Quality of life is assessed at the first and last day of radiotherapy, at 1 month, 3 months, and then every 3 months until disease progression. Patients are followed at 1 month, 3 months, every 3 months until disease progression, and then for survival. PROJECTED ACCRUAL: A maximum of 408 (204 per treatment arm) patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Radiographically, histologically, or cytologically confirmed brain metastases with histologically or cytologically confirmed primary malignancy except the following: Small cell lung cancer, germ cell tumors, and lymphomas - No leptomeningeal metastases --Prior/Concurrent Therapy-- - Biologic therapy: No prior biologic therapy or immunotherapy for brain metastases; At least 28 days since prior investigational biologic therapy - Chemotherapy: No prior chemotherapy for brain metastases; No chemotherapy for brain metastases for at least one month following radiation therapy; At least 7 days since prior chemotherapy for primary tumor or extracranial metastases; No planned chemotherapy during radiation therapy - Endocrine therapy: No prior hormonal therapy for brain metastases; Prior or concurrent corticosteroid therapy allowed - Radiotherapy: No prior whole brain radiotherapy for brain metastases; No prior stereotactic radiosurgery for brain metastases - Surgery: Prior surgery allowed for brain metastases if at least one measurable lesion remains - Other: At least 28 days since prior investigational drug or device; No prior RSR13 --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 70-100% - Life expectancy: Not specified - Hematopoietic: Hemoglobin at least 10 g/dL; WBC at least 2,000/mm3; Platelet count at least 75,000/mm3 - Hepatic: Bilirubin no greater than 2.0 mg/dL ALT and AST no greater than 3 times upper limit of normal - Renal: Creatinine no greater than 2.0 mg/dL - Pulmonary: Forced vital capacity and forced expiratory volume at least 50% of normal in patients with significant intrathoracic tumor involvement, chronic obstructive pulmonary disease, interstitial lung disease, or pulmonary embolism; Resting and exercise oxygen saturation at least 90% on room air - Other: No other concurrent active malignancy from a second histologic site; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EdwardShaw, Study Chair, Allos Therapeutics
St. Agnes Healthcare
Baltimore, Maryland, 21229
United States
Arizona Cancer Center
Tucson, Arizona, 85724
United States
Center for Radiation Oncology
Danville, Virginia, 24541
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
Millard Fillmore Hospital
Buffalo, New York, 14209
United States
CHUS-Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4
Canada
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Comprehensive Cancer Care Specialists of Boca Raton
Boca Raton, Florida, 33428
United States
University of Debrecen
Debrecen, , 1389/990TE-
Hungary
Ochsner Clinic
New Orleans, Louisiana, 70121
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Szeged University
Szeged, , H-6720
Hungary
Radiologische Uniklink
Freiburg, , D-79106
Germany
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, A1B 3V6
Canada
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
Royal Prince Alfred Hospital Medical Center
Sydney, New South Wales, 2042
Australia
British Columbia Cancer Agency - Fraser Valley Cancer Centre
Surrey, British Columbia, V3V 1Z2
Canada
Monmouth Medical Center
Long Branch, New Jersey, 07740-6395
United States
Uzsoki Hospital
Budapest, , 1145
Hungary
Universitats-Krankenhaus Eppendorf
Hamburg, , D-20246
Germany
Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
United Kingdom
Tower Hematology Oncology Medical Group
Los Angeles, California, 90048
United States
U.S. Oncology Research Inc.
Dallas, Texas, 75246
United States
Harbor Hospital Center
Baltimore, Maryland, 21225
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, G1R 2J6
Canada
McGill University
Montreal, Quebec, H2W 1S6
Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Canada
Bismarck Cancer Center
Bismark, North Dakota, 58501-4445
United States
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103
United States
Memphis Regional Brain Tumor Center
Memphis, Tennessee, 38104
United States
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
Canada
Centre Hospitalier Lyon Sud
Pierre-Benite, , 69310
France
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Austin and Repatriation Medical Centre
Heidelberg West, Victoria, 3081
Australia
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85001-2071
United States
Citrus Memorial Hospital
Inverness, Florida, 34452
United States
Akron General Medical Center
Akron, Ohio, 44302
United States
Borsod-Abauj-Zemplen County Hospital
Miskolc, , 3501
Hungary
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
Canada
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Western General Hospital
Edinburgh, Scotland, EH4 2XU
United Kingdom
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Canada
Scripps Green Hospital & Scripps Clinic
La Jolla, California, 92037
United States
Akron City Hospital
Akron, Ohio, 44309
United States
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
Centro di Riferimento Oncologico - Aviano
Aviano, , 33081
Italy
Institut Jules Bordet
Brussels (Bruxelles), , 1000
Belgium
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
UZ De Pintelaan
GENT, , B-9000
Belgium
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels (Bruxelles), , 1090
Belgium
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
United States
CHU de la Timone
Marseille, , 13385
France
Lahey Clinic - Burlington
Burlington, Massachusetts, 01805
United States
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2L-4M1
Canada
Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
Dijon, , 21079
France
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Canada
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526
United States
Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group
Memphis, Tennessee, 38119
United States
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Istituto Europeo Di Oncologia
Milano, , 20141
Italy
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704
United States
Queensland Radium Institute
HERSTON, Queensland, 4029
Australia
Peter MacCallum Cancer Institute
East Melbourne, Victoria, 8006
Australia
East Coast Radiation Oncology
Toms River, New Jersey, 08755
United States
Petz Aladar County Hospital
Gydr, , h-9024
Hungary
California Cancer Care, Inc.
Greenbrae, California, 94904
United States
Hopital de Montbeliard
Montbeliard, , 25200
France
Additional Information:
Study ID Numbers: CDR0000067957; ALLOS-RSR13RT-009
Study Start Date: February 2000
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005887
Other Brain Metastases Studies:
1. Radiation Therapy With or Without Radiosurgery in Treating Patients With Brain Metastases
2. Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases
3. Temozolomide and Radiation Therapy in Treating Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Cancer Involving the Central Nervous System
4. Radiation Therapy Plus Thalidomide and Temozolomide in Treating Patients With Newly Diagnosed Brain Metastases
5. Temozolomide With or Without Radiation Therapy to the Brain in Treating Patients With Stage IV Melanoma That Is Metastatic to the Brain
Related Studies:
Other brain metastases Clinical Trials
Other Queensland Clinical Trials
Other HERSTON Clinical Trials
Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases
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