Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003759
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
1999-11-01
Brief Title:
AD 32 With or Without BCG After Surgery in Treating Patients With Newly Diagnosed or Recurrent Superficial Bladder Cancer
Sponsor:
Anthra Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Intravesical Treatment of Superficial Bladder Cancer Characterized on the Basis of the Tumor Markers p53 and pRb
Status:
COMPLETED
Status Verified Date:
2002-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ANTHRA-A9701ID97-038 | None | None | None |
| MDA-ID-97038 | None | None | None |