Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003638
Status:
COMPLETED
Last Update Posted:
2013-03-26
First Post:
1999-11-01
Brief Title:
Vaccine Therapy in Treating Women With Metastatic Breast Cancer
Sponsor:
Oncothyreon Canada Inc
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multi-Center Phase III Randomized Controlled Study of Theratope Vaccine for Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2008-12
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 Vaccines may make the body build an immune response to kill tumor cells It is not yet known whether THERATOPE vaccine therapy is more effective than standard vaccine therapy in treating metastatic breast cancer
PURPOSE Randomized double blinded phase III trial to compare the effectiveness of THERATOPE vaccine therapy with that of standard vaccine therapy in treating women who have metastatic breast cancer
PURPOSE Randomized double blinded phase III trial to compare the effectiveness of THERATOPE vaccine therapy with that of standard vaccine therapy in treating women who have metastatic breast cancer
Detailed Description:
OBJECTIVES I Compare time to disease progression in patients receiving THERATOPE vaccine to that of women receiving control vaccine II Compare survival in patients receiving THERATOPE vaccine to that of patients receiving control vaccine III Document the product safety profile in these patients IV Measure the anti-STn anti-OSM and anti-KLH antibody titers V Evaluate the impact of THERATOPE STn-KLH vaccine on health-related quality of life in these patients
OUTLINE The study design is a prospective double-blinded randomized study Patients who have completed first-line chemotherapy for metastatic breast cancer and have either nonprogressive disease or no evidence of disease following completion of first-line chemotherapy includes bone marrow transplants and stem cell rescue will be randomized to either the THERATOPE vaccine or the control vaccine Patients are stratified at entry according to disease status ie either no evidence of disease or nonprogressive disease and whether or not they are receiving hormonal therapy for metastatic disease while on study Arm I Patients receive intravenous cyclophosphamide on day -3 followed by 4 subcutaneous vaccinations with THERATOPE STn-KLH vaccine combined with Detox-B Stable Emulsion at 0 2 5 and 9 weeks Arm II Patients receive the control treatment of intravenous cyclophosphamide on day -3 followed by 4 subcutaneous vaccinations with keyhole limpet hemocyanin KLH vaccine combined with Detox-B Stable Emulsion at 0 2 5 and 9 weeks Patients with stable or responding disease may receive the THERATOPE STn-KLH vaccine or control without Detox-B Stable Emulsion at weeks 13 17 21 and 25 Patients without unacceptable toxic effects or disease progression may continue on maintenance therapy at 3 month intervals
PROJECTED ACCRUAL Over 120 sites in North America Europe and AustraliaNew Zealand will be participating in the study A total of 950 women 475 per treatment arm will be enrolled into the study
OUTLINE The study design is a prospective double-blinded randomized study Patients who have completed first-line chemotherapy for metastatic breast cancer and have either nonprogressive disease or no evidence of disease following completion of first-line chemotherapy includes bone marrow transplants and stem cell rescue will be randomized to either the THERATOPE vaccine or the control vaccine Patients are stratified at entry according to disease status ie either no evidence of disease or nonprogressive disease and whether or not they are receiving hormonal therapy for metastatic disease while on study Arm I Patients receive intravenous cyclophosphamide on day -3 followed by 4 subcutaneous vaccinations with THERATOPE STn-KLH vaccine combined with Detox-B Stable Emulsion at 0 2 5 and 9 weeks Arm II Patients receive the control treatment of intravenous cyclophosphamide on day -3 followed by 4 subcutaneous vaccinations with keyhole limpet hemocyanin KLH vaccine combined with Detox-B Stable Emulsion at 0 2 5 and 9 weeks Patients with stable or responding disease may receive the THERATOPE STn-KLH vaccine or control without Detox-B Stable Emulsion at weeks 13 17 21 and 25 Patients without unacceptable toxic effects or disease progression may continue on maintenance therapy at 3 month intervals
PROJECTED ACCRUAL Over 120 sites in North America Europe and AustraliaNew Zealand will be participating in the study A total of 950 women 475 per treatment arm will be enrolled into the 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 |
|---|---|---|---|
| NCI-V98-1489 | None | None | None |
| BIOMIRA-STn-BR-104 | None | None | None |