Track topics on Twitter Track topics that are important to you
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 is more effective with or without BCG after surgery for superficial bladder cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of AD 32 with or without BCG after surgery in treating patients who have newly diagnosed or recurrent superficial bladder cancer.
- 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.
- For low-risk patients, assess the efficacy of peri-operative AD 32 in preventing tumor recurrence.
- 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.
- Evaluate systemic exposure and urine recovery of AD 32 through pharmacokinetic analysis in a subset of patients.
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.
After 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.
Allocation: Randomized, Control: Active Control, Masking: Open Label, Primary Purpose: Treatment
BCG vaccine, valrubicin, conventional surgery
University of Texas - MD Anderson Cancer Center
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:58:32-0400
RATIONALE: Transurethral resection is a less invasive type of surgery for bladder cancer and may have fewer side effects and improve recovery. Drugs used in chemotherapy use different ways...
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Placing a vaccine directly into the bladder may cause a stronger immune response and kill more tumor cel...
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of chemotherapy ...
This randomized phase III trial studies Tokyo-172 strain bacillus Calmette-Guerin (BCG) solution with or without a vaccination using Tokyo-172 strain BCG to see how well it works compared ...
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from div...
Intravesical instillation of bacillus Calmette-Guérin (BCG) has been a first-line therapy for non-muscle-invasive bladder cancer for the last 4 decades. However, this treatment causes serious adverse...
Radical cystectomy currently remains the standard of care for muscle-invasive bladder cancer. However, surgery can be associated with considerable morbidity and mortality, including the removal of the...
Smoking is a major risk factor for bladder cancer, but the relationship between smoking cessation after initial treatment and bladder cancer recurrence has been investigated less frequently and not pr...
To investigate the expression of amyloid precursor protein in bladder cancer, and to study its role in malignant bladder cancer cell behaviors.
Bladder cancer is one of the most common cancers among urologic cancers. Intravesical instillation following transurethral resection of bladder tumor (TURBT) is used as a treatment of bladder cancer. ...
Tumors or cancer of the URINARY BLADDER.
A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.
A live vaccine containing attenuated poliovirus, types I, II, and III, grown in monkey kidney cell tissue culture, used for routine immunization of children against polio. This vaccine induces long-lasting intestinal and humoral immunity. Killed vaccine induces only humoral immunity. Oral poliovirus vaccine should not be administered to immunocompromised individuals or their household contacts. (Dorland, 28th ed)
A bacterial vaccine for the prevention of brucellosis in man and animal. Brucella abortus vaccine is used for the immunization of cattle, sheep, and goats.
A live attenuated virus vaccine of chick embryo origin, used for routine immunization of children and for immunization of adolescents and adults who have not had mumps or been immunized with live mumps vaccine. Children are usually immunized with measles-mumps-rubella combination vaccine.
Biological therapy involves the use of living organisms, substances derived from living organisms, or laboratory-produced versions of such substances to treat disease. Some biological therapies for cancer use vaccines or bacteria to stimulate the body&rs...
An antibody is a protein produced by the body's immune system when it detects harmful substances, called antigens. Examples of antigens include microorganisms (such as bacteria, fungi, parasites, and viruses) and chemicals. Antibodies may be produc...
Head and neck cancers
Cancer can occur in any of the tissues or organs in the head and neck. There are over 30 different places that cancer can develop in the head and neck area. Mouth cancers (oral cancers) - Mouth cancer can develop on the lip, the tongue, the floor...