|
Tipifarnib in Treating Patients With Recurrent Bladder Cancer Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Tipifarnib in Treating Patients With Recurrent Bladder Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Tipifarnib in Treating Patients With Recurrent Bladder Cancer Clinical research trials and Tipifarnib in Treating Patients With Recurrent Bladder Cancer health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Tipifarnib in Treating Patients With Recurrent Bladder Cancer. Tipifarnib in Treating Patients With Recurrent Bladder Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Tipifarnib in Treating Patients With Recurrent Bladder Cancer clinical trial. Human subjects frequently get the finest healthcare available for their Tipifarnib in Treating Patients With Recurrent Bladder Cancer condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > Tipifarnib in Treating Patients With Recurrent Bladder Cancer  Tipifarnib in Treating Patients With Recurrent Bladder Cancer
Tipifarnib in Treating Patients With Recurrent Bladder Cancer
For Condition: stage 1 bladder cancer,recurrent bladder cancer,stage 0 bladder cancer,transitional cell carcinoma of the bladder
Status: Recruiting
Sponsor(s): Princess Margaret Hospital , National Cancer Institute (NCI)
Synopsis: RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of tipifarnib in treating patients who have recurrent bladder cancer.
Details: OBJECTIVES: - Determine the 1-year recurrence-free survival rate of patients with stage 0 or I recurrent transitional cell carcinoma of the bladder treated with tipifarnib. OUTLINE: This is a multicenter study. Patients receive oral tipifarnib twice daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study within 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed transitional cell carcinoma (TCC) of the bladder with or without associated carcinoma in situ - Stage 0 or I (Ta or T1) - Grade 1, 2, or 3 TCC - Cystoscopically and histologically confirmed recurrent disease after at least 1 course of standard first-line intravesical therapy (e.g., BCG or mitomycin) within the past 12 months - Complete transurethral resection of bladder tumor performed within past 4 weeks - Rendered clinically and cystoscopically tumor free - Negative cytology - No upper tract TCC by intravenous pyelogram, retrograde pyelogram, or CT scan of kidneys (with contrast) PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 1 year Hematopoietic - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin normal - AST/ALT no greater than 2.5 times upper limit of normal (ULN) Renal - Creatinine no greater than 1.25 times ULN OR - Creatinine clearance at least 60 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia - No uncontrolled hypertension Other - Able to swallow and retain oral medication - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergic reactions to compounds of similar chemical or biological composition to study drug (e.g., other imidazoles such as ketoconazole and other imidazole-based antifungal agents, losartan, metronidazole, or cimetidine) - No other prior or concurrent malignancy within the past 5 years except nonmelanomatous skin cancer - No other uncontrolled concurrent illness that would preclude study participation - No ongoing or active infection - No active peptic ulcer disease - No psychiatric illness or social situation that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - No prior systemic chemotherapy for bladder cancer Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy for bladder cancer Surgery - See Disease Characteristics Other - No single-dose post-transurethral resection (TUR) adjuvant intravesical therapy (after TUR that is performed immediately preceding study entry) - At least 4 weeks since prior investigational agents - No concurrent commercial or other investigational agents or therapies for malignancy - No other concurrent therapy for bladder cancer - No concurrent combination anti-retroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JosephChin, Study Chair, London Health Sciences Centre
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Walter Stadler 773-702-4400
Hamilton and District Urology Association *Recruiting*
Hamilton, Ontario, L8N 1T8
Canada
Recruiting J. Whelan 905-528-1266
Princess Margaret Hospital *Recruiting*
Toronto, Ontario, M5G 2M9
Canada
Recruiting Michael Jewett 416-946-2909
Louis A. Weiss Memorial Hospital *Recruiting*
Chicago, Illinois, 60640
United States
Recruiting Gary Steinberg 773-564-5272
London Health Sciences Centre *Recruiting*
London, Ontario, N6A 4G5
Canada
Recruiting Joseph Chin 519-685-8451
Additional Information:
Study ID Numbers: CDR0000257564; PMH-PHL-007,NCI-5612
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00047216
Other Stage 1 Bladder Cancer Studies:
1. Keyhole Limpet Hemocyanin Compared With Doxorubicin in Treating Patients With Bladder Cancer
2. Gene Therapy in Treating Patients With Advanced Bladder Cancer
3. Arsenic Trioxide in Treating Patients With Recurrent Bladder or Urinary Tract Cancer
4. BCG Plus Interferon alfa 2b in Treating Patients With Bladder Cancer
5. Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer
Related Studies:
Other stage 1 bladder cancer Clinical Trials
Other Ontario Clinical Trials
Other London Clinical Trials
Tipifarnib in Treating Patients With Recurrent Bladder Cancer
|
|
|
|
|
|
|
|
