Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00095862
Status:
TERMINATED
Last Update Posted:
2018-02-05
First Post:
2004-11-09
Brief Title:
Vaccine Therapy in Treating Patients With HER2Neu Positive or Negative Stage IV Breast Cancer or Other HER2Neu Positive Cancers
Sponsor:
Wiseman Research Initiatives LLC
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 1-2 Study for Stage IV Breast and HER2Neu Positive Cancers to Evaluate the Safety and Efficacy of a Vaccine Using Whole Cells From the SVBR- 1-GM Cell Line Genetically Engineered To Produce Granulocyte- Macrophage Colony Stimulating Factor
Status:
TERMINATED
Status Verified Date:
2011-10
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 Vaccines made from gene-modified tumor cells may make the body build an immune response to kill tumor cells Drugs used in chemotherapy such as cyclophosphamide work in different ways to stop tumor cells from dividing so they stop growing or die Interferon alfa may interfere with the growth of tumor cells Combining vaccine therapy with cyclophosphamide and interferon alfa may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combining vaccine therapy with interferon alfa and cyclophosphamide in treating patients who have stage IV breast cancer
PURPOSE Phase I trial to study the effectiveness of combining vaccine therapy with interferon alfa and cyclophosphamide in treating patients who have stage IV breast cancer
Detailed Description:
OBJECTIVES
Determine the safety tolerability and feasibility of vaccine therapy comprising an allogeneic non-self tumor cell line transfected with the sargramostim GM-CSF gene combined with low-dose interferon alfa and low-dose cyclophosphamide in patients with stage IV breast cancer or other solid tumors
Determine the clinical response time to progression and survival of patients treated with this regimen
Correlate clinical response with immunological response in patients treated with this regimen
OUTLINE Patients receive low-dose cyclophosphamide IV once 2-3 days before each tumor vaccine Patients then receive tumor vaccine comprising HER2neu-positive allogeneic non-self breast cancer cells transfected with the sargramostim GM-CSF gene intradermally ID on day 1 Patients also receive low-dose interferon alfa ID approximately 48 and 96 hours after each tumor vaccine Treatment repeats every 2 weeks for 3 vaccinations and then monthly for 3 vaccinations in the absence of disease progression or unacceptable toxicity
Patients are followed at 2 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 9-24 patients will be accrued for this study
Determine the safety tolerability and feasibility of vaccine therapy comprising an allogeneic non-self tumor cell line transfected with the sargramostim GM-CSF gene combined with low-dose interferon alfa and low-dose cyclophosphamide in patients with stage IV breast cancer or other solid tumors
Determine the clinical response time to progression and survival of patients treated with this regimen
Correlate clinical response with immunological response in patients treated with this regimen
OUTLINE Patients receive low-dose cyclophosphamide IV once 2-3 days before each tumor vaccine Patients then receive tumor vaccine comprising HER2neu-positive allogeneic non-self breast cancer cells transfected with the sargramostim GM-CSF gene intradermally ID on day 1 Patients also receive low-dose interferon alfa ID approximately 48 and 96 hours after each tumor vaccine Treatment repeats every 2 weeks for 3 vaccinations and then monthly for 3 vaccinations in the absence of disease progression or unacceptable toxicity
Patients are followed at 2 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 9-24 patients 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 |
|---|---|---|---|
| WRI-GEV-007 | None | None | None |