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Arsenic Trioxide in Treating Patients With Recurrent Bladder or Urinary Tract Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Arsenic Trioxide in Treating Patients With Recurrent Bladder or Urinary Tract Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Arsenic Trioxide in Treating Patients With Recurrent Bladder or Urinary Tract Cancer Clinical research trials and Arsenic Trioxide in Treating Patients With Recurrent Bladder or Urinary Tract Cancer healthcare trials happen in many 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 drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Arsenic Trioxide in Treating Patients With Recurrent Bladder or Urinary Tract Cancer. Arsenic Trioxide in Treating Patients With Recurrent Bladder or Urinary Tract Cancer Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Arsenic Trioxide in Treating Patients With Recurrent Bladder or Urinary Tract Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Arsenic Trioxide in Treating Patients With Recurrent Bladder or Urinary Tract Cancer condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Arsenic Trioxide in Treating Patients With Recurrent Bladder or Urinary Tract Cancer  Arsenic Trioxide in Treating Patients With Recurrent Bladder or Urinary Tract Cancer
Arsenic Trioxide in Treating Patients With Recurrent Bladder or Urinary Tract Cancer
For Condition: recurrent transitional cell cancer of the renal pelvis and ureter,recurrent urethral cancer,transitional cell carcinoma of the bladder,recurrent bladder cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B
Synopsis: RATIONALE: Arsenic trioxide may kill tumor cells that have become resistant to standard chemotherapy regimens. PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have recurrent cancer of the bladder or urinary tract.
Details: OBJECTIVES: I. Determine the efficacy of arsenic trioxide in patients with recurrent urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis. II. Determine the toxicity of this drug in these patients. PROTOCOL OUTLINE: Patients receive arsenic trioxide IV over 1 hour on days 1-5. Treatment repeats every 28 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response receive 2 additional courses. Patients are followed every 2 months for 1 year after registration and then every 6 months for 1 year or until disease progression or relapse. PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 12-18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis; Histologic documentation of metastatic or recurrent disease is not required; Clinical (not pathological) staging is required - Measurable disease; At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan Nonmeasurable disease defined as any of the following: Bone lesions; Leptomeningeal disease; Ascites; Pleural/pericardial effusion; Lymphangitis cutis/pulmonis; Abdominal masses not confirmed or followed by imaging techniques; Cystic lesions; Primary bladder masses - Relapse from or failure to achieve complete or partial response after 1 chemotherapy regimen that included cisplatin, carboplatin, paclitaxel, or gemcitabine --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy; No other concurrent chemotherapy - Endocrine therapy: No concurrent hormonal therapy except for non-disease related conditions (e.g., insulin for diabetes) and steroids for adrenal failure - Radiotherapy: Prior palliative radiotherapy allowed for symptomatic lesions or in case of disability (e.g., unstable femur) provided other measurable disease is present; At least 4 weeks since prior radiotherapy; No concurrent palliative radiotherapy - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-1 - Life expectancy: Not specified - Hematopoietic: Granulocyte count greater than 1,500/mm3; Platelet count greater than 100,000/mm3 - Hepatic: Bilirubin no greater than upper limit of normal (ULN) - Renal: Creatinine less than 2 times ULN - Cardiovascular: No New York Heart Association class III or IV heart disease; Electrocardiogram QTc less than 500 msec - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No other concurrent active malignancy (greater than 30% risk of relapse) except nonmelanoma skin cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DeanBajorin, Study Chair, Cancer and Leukemia Group B
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233-1996
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, 52722
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
CCOP - Greenville
Greenville, South Carolina, 29615
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
CCOP - Southwestern Vermont Regional Cancer Center
Bennington, Vermont, 05201
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, 60612
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
United States
Additional Information:
Study ID Numbers: CDR0000068419; CLB-99903
Study Start Date: February 2001
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00009867
Other Transitional Cell Carcinoma Of The Bladder Studies:
1. BCG Plus Interferon alfa 2b in Treating Patients With Bladder Cancer
2. Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer
3. Gemcitabine in Treating Patients With Recurrent or Refractory Bladder Cancer
4. Ciprofloxacin Compared With Cephalexin in Treating Patients With Bladder Cancer
5. R115777 in Treating Patients With Advanced Bladder Cancer
Related Studies:
Other transitional cell carcinoma of the bladder Clinical Trials
Other New York Clinical Trials
Other Syracuse Clinical Trials
Arsenic Trioxide in Treating Patients With Recurrent Bladder or Urinary Tract Cancer
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