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AD 32 Alone or With BCG Following Surgery in Treating Patients With Newly Diagnosed or Recurrent Superficial Bladder Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about AD 32 Alone or With BCG Following Surgery in Treating Patients With Newly Diagnosed or Recurrent Superficial Bladder Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. AD 32 Alone or With BCG Following Surgery in Treating Patients With Newly Diagnosed or Recurrent Superficial Bladder Cancer Clinical research trials and AD 32 Alone or With BCG Following Surgery in Treating Patients With Newly Diagnosed or Recurrent Superficial Bladder Cancer health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like AD 32 Alone or With BCG Following Surgery in Treating Patients With Newly Diagnosed or Recurrent Superficial Bladder Cancer. AD 32 Alone or With BCG Following Surgery in Treating Patients With Newly Diagnosed or Recurrent Superficial Bladder Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a AD 32 Alone or With BCG Following Surgery in Treating Patients With Newly Diagnosed or Recurrent Superficial Bladder Cancer clinical trial. Subjects frequently get the best healthcare possible for their AD 32 Alone or With BCG Following Surgery in Treating Patients With Newly Diagnosed or Recurrent Superficial Bladder Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > AD 32 Alone or With BCG Following Surgery in Treating Patients With Newly Diagnosed or Recurrent Superficial Bladder Cancer  AD 32 Alone or With BCG Following Surgery in Treating Patients With Newly Diagnosed or Recurrent Superficial Bladder Cancer
AD 32 Alone or With BCG Following Surgery in Treating Patients With Newly Diagnosed or Recurrent Superficial Bladder Cancer
For Condition: stage 1 bladder cancer,stage 0 bladder cancer,recurrent bladder cancer
Status: Completed
Sponsor(s): Anthra Pharmaceuticals ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as BCG use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known whether AD 32 alone is more effective than AD 32 plus BCG following surgery for superficial bladder cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of AD 32 alone or with BCG following surgery in treating patients who have newly diagnosed or recurrent superficial bladder cancer.
Details: OBJECTIVES: I. Evaluate the efficacy of peri-operative intravesical AD 32 alone or supplemented with BCG in patients with newly diagnosed or recurrent superficial bladder cancer characterized as either high risk or low risk based on the tumor markers p53 and pRb. II. For low risk patients, assess the efficacy of peri-operative AD 32 in preventing tumor recurrence. III. For high risk patients, assess the efficacy of combined intravesical therapy with AD 32 administered within 8 hours after transurethral resection along with BCG in decreasing the incidence of tumor progression. IV. Evaluate systemic exposure and urine recovery of AD 32 through pharmacokinetic analysis in a subset of patients. PROTOCOL OUTLINE: This is a randomized, open label study. All patients undergo complete transurethral resection to remove bladder tumors. AD 32 is administered by catheter into the bladder within 8 hours after surgery. Patients must hold the AD 32 in the bladder for 90 minutes. Following pathological and tumor marker analysis, patients are assigned to the low or high risk group as defined by their p53 and pRb phenotype. Low risk patients with carcinoma in situ receive BCG by catheter into the bladder once weekly for 6 weeks beginning 7-21 days after treatment with AD 32. Patients assigned to the low risk group who do not have carcinoma in situ receive no further treatment. High risk patients also receive BCG once weekly for 6 weeks, and then once weekly for 3 weeks at 3 months, 6 months, and then every 6 months for a total of 3 years after the first BCG treatment. All patients undergo cystoscopy every 3 months for the first year, and then every 6 months for the next 2 years. PROJECTED ACCRUAL: Approximately 200 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-- Newly diagnosed or recurrent (at least 2 occurrences within 12 months) Ta, multifocal Ta (at least 2 visible tumors), or stage T1 bladder cancer - No carcinoma in situ (Tis) only - No T2 or greater tumors No evidence of upper tract (ureter or renal pelvic) transitional cell carcinoma based on intravenous pyelogram performed within 4 months of the TURB --Prior/Concurrent Therapy-- Biologic therapy: No concurrent biological response modifiers Chemotherapy: No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: No concurrent radiotherapy Surgery: Not specified --Patient Characteristics-- Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: - WBC greater than 3,500/mm3 - Platelet count greater than 100,000/mm3 Hepatic: Not specified Renal: Not specified Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or superficial transitional cell carcinoma of the bladder
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ColinN. Dinney, Study Chair, Anthra Pharmaceuticals
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Additional Information:
Study ID Numbers: CDR0000066883; ANTHRA-A9701/ID97-038,MDA-ID-97038
Study Start Date: November 1998
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003759
Other Stage 1 Bladder Cancer Studies:
1. High-Dose Multivitamins Compared to a Placebo in Preventing the Recurrence of Cancer in Patients With Early Stage Bladder Cancer
2. Fenretinide to Prevent Cancer Recurrence in Treating Patients With Bladder Cancer
3. Eflornithine in Treating Patients With Bladder Cancer
4. Gemcitabine in Treating Patients With Recurrent or Refractory Bladder Cancer
5. Suramin in Treating Patients With Recurrent Bladder Cancer
Related Studies:
Other stage 1 bladder cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
AD 32 Alone or With BCG Following Surgery in Treating Patients With Newly Diagnosed or Recurrent Superficial Bladder Cancer
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