Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006034
Status:
COMPLETED
Last Update Posted:
2013-05-15
First Post:
2000-07-05
Brief Title:
Keyhole Limpet Hemocyanin Compared With Doxorubicin in Treating Patients With Bladder Cancer
Sponsor:
Intracel
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Multicenter Phase III Trial Evaluating the Efficacy and Safety of BCI-ImmuneActivator Versus Adriamycin in BCG Refractory or Intolerant Patients With Carcinoma in Situ With or Without Resected Superficial Papillary Bladder Cancer
Status:
COMPLETED
Status Verified Date:
2006-01
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 Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known whether keyhole limpet hemocyanin is more effective than doxorubicin for bladder cancer
PURPOSE Randomized phase III trial to compare the effectiveness of keyhole limpet hemocyanin with that of doxorubicin in treating patients who have bladder cancer that has not responded to BCG or in those patients who cannot tolerate BCG
PURPOSE Randomized phase III trial to compare the effectiveness of keyhole limpet hemocyanin with that of doxorubicin in treating patients who have bladder cancer that has not responded to BCG or in those patients who cannot tolerate BCG
Detailed Description:
OBJECTIVES
Compare the efficacy of BCI-ImmuneActivator keyhole limpet hemocyanin versus doxorubicin in BCG refractory or intolerant patients with carcinoma in situ with or without resected superficial papillary bladder cancer
Compare the toxicity and safety of these treatments in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center and prior BCG response refractory vs intolerant Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive a sensitizing dose of keyhole limpet hemocyanin KLH intradermally at week -2 followed by induction KLH IV once weekly at weeks 1-6 Patients with partial or no response receive IV KLH reinduction therapy once weekly at weeks 13-18 Patients with complete response receive IV KLH maintenance therapy monthly at weeks 13 17 and 21 and then at months 6-12
Arm II Patients receive doxorubicin IV once weekly at weeks 1-6 Patients with complete response receive maintenance therapy comprising doxorubicin IV at weeks 13 17 and 21 and months 6-12
Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 15 years and then every 6 months for 1 year Patient total participation in this study may last as long as 42 months
PROJECTED ACCRUAL A total of 150 patients 75 per treatment arm will be accrued for this study
Compare the efficacy of BCI-ImmuneActivator keyhole limpet hemocyanin versus doxorubicin in BCG refractory or intolerant patients with carcinoma in situ with or without resected superficial papillary bladder cancer
Compare the toxicity and safety of these treatments in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center and prior BCG response refractory vs intolerant Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive a sensitizing dose of keyhole limpet hemocyanin KLH intradermally at week -2 followed by induction KLH IV once weekly at weeks 1-6 Patients with partial or no response receive IV KLH reinduction therapy once weekly at weeks 13-18 Patients with complete response receive IV KLH maintenance therapy monthly at weeks 13 17 and 21 and then at months 6-12
Arm II Patients receive doxorubicin IV once weekly at weeks 1-6 Patients with complete response receive maintenance therapy comprising doxorubicin IV at weeks 13 17 and 21 and months 6-12
Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 15 years and then every 6 months for 1 year Patient total participation in this study may last as long as 42 months
PROJECTED ACCRUAL A total of 150 patients 75 per treatment arm will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068047 | REGISTRY | PDQ Physician Data Query | None |