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Gene Therapy in Treating Patients With Advanced Bladder Cancer 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 Gene Therapy in Treating Patients With Advanced Bladder Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Gene Therapy in Treating Patients With Advanced Bladder Cancer Clinical research trials and Gene Therapy in Treating Patients With Advanced Bladder Cancer 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 Gene Therapy in Treating Patients With Advanced Bladder Cancer. Gene Therapy in Treating Patients With Advanced Bladder Cancer 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 Gene Therapy in Treating Patients With Advanced Bladder Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Gene Therapy in Treating Patients With Advanced Bladder Cancer 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 > "G" Clinical Trials Conditions > Gene Therapy in Treating Patients With Advanced Bladder Cancer  Gene Therapy in Treating Patients With Advanced Bladder Cancer
Gene Therapy in Treating Patients With Advanced Bladder Cancer
For Condition: stage 4 bladder cancer,stage 1 bladder cancer,stage 2 bladder cancer,transitional cell carcinoma of the bladder,stage 3 bladder cancer,recurrent bladder cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , M.D. Anderson Cancer Center
Synopsis: RATIONALE: Inserting the p53 gene into a person's bladder cancer cells may improve the body's ability to fight cancer. PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients with advanced bladder cancer.
Details: OBJECTIVES: I. Determine the safety and toxicity of adenovirus p53 (Ad-p53) gene therapy in patients with locally advanced or metastatic bladder cancer. II. Measure infection with Ad-p53 and confirm expression of p53 after infection. III. Characterize clinical response of measurable tumor in these patients. IV. Determine the duration of effect of this treatment in these patients. V. Define the time course of elimination of vector from urinary bladder. PROTOCOL OUTLINE: This is a dose escalation study. Group 1 patients receive adenovirus p53 (Ad-p53) intravesically on days 1 and 4. Treatment continues every 4 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3 patients in group 1 receive escalating doses of Ad-p53. In the absence of grade 3 or worse toxicity in the first 3 patients treated, subsequent cohorts of 3 patients each receive escalating doses of Ad-p53 on the same schedule. If 1 of 3 patients experiences grade 3 toxicity, an additional 3 patients are treated at that dose level and dose escalation continues. If 1 of 3 patients experience grade 4 toxicity or 2 of 3 patients experience grade 3 toxicity, dose escalation ceases and the MTD is defined as the previous dose level. Group 2 patients receive Ad-p53 at the MTD on days 1-4, and group 3 patients receive Ad-p53 at the MTD on days 1-4 and 8-11. Patients are followed on day 28, then every 3 months for 1 year or until disease progression. PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study (3-12 patients for group 1; 3-6 patients for group 2; and 6 patients for group 3).
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 with muscle invasion or lamina propria invasion (T1-4); Patients without muscle invasion (T1) must have concurrent carcinoma in situ (CIS)or recurrent/persistent tumor following at least 1 course of intravesical BCG immunotherapy OR Patients who have received BCG and have only CIS are eligible if lesions are sufficiently raised and measurable - Bidimensionally measurable disease - Unresectable locally advanced disease OR Asymptomatic distant visceral metastases OR Refused cystectomy - Recurrent disease after prior chemotherapy OR Patients with muscle invasion must have failed prior cisplatin-based chemotherapy --Prior/Concurrent Therapy-- - Biologic therapy: No prior gene therapy - Chemotherapy: See Disease Characteristics; At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea) and recovered - Endocrine therapy: Not specified - Radiotherapy: At least 6 weeks since prior radiotherapy - Surgery: No prior transurethral resection if all visible tumor removed; Partial resection for diagnosis allowed - Other: No other concurrent investigational agents --Patient Characteristics-- - Age: 18 and over - Performance status: Zubrod 0-2 - Life expectancy: Greater than 12 weeks - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified - Other: Must have at least minimal control of bladder function (NCI grade 3 incontinence not eligible); Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective barrier contraception; HIV negative; No active viral, bacterial, or fungal infection requiring treatment; No serious concurrent illness or psychological, familial, sociological, geographical, or other conditions that would prevent compliance; Urine culture (14-day) negative for adenovirus
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LancePagliaro, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Additional Information:
Study ID Numbers: CDR0000065968; MDA-DM-96172,NCI-T96-0073
Study Start Date: May 1998
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003167
Other Transitional Cell Carcinoma Of The Bladder Studies:
1. Combination Chemotherapy and Radiation Therapy With or Without Surgery In Treating Patients With Stage II or Stage III Bladder Cancer
2. R115777 in Treating Patients With Advanced Bladder Cancer
3. Gene Therapy in Treating Patients With Advanced Bladder Cancer
4. Cisplatin and Gemcitabine Compared With Observation in Treating Patients Who Have Undergone Surgery for Bladder Cancer
5. Gemcitabine, Cisplatin, and Amifostine Following Surgery in Treating Patients With Locally Advanced Bladder Cancer
Related Studies:
Other transitional cell carcinoma of the bladder Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Gene Therapy in Treating Patients With Advanced Bladder Cancer
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