Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003761
Status:
COMPLETED
Last Update Posted:
2017-02-15
First Post:
1999-11-01
Brief Title:
Vaccine Therapy in Treating Patients With Metastatic Breast Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase I Trial of Recombinant Vaccinia Virus That Expresses DF3MUC1 in Patients With Metastatic Adenocarcinoma of the Breast
Status:
COMPLETED
Status Verified Date:
2017-02
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:
This protocol is designed to evaluate the side effects of rV-DF3MUC1 and to determine the safest dose which should be used in the treatment of breast cancer
Detailed Description:
OBJECTIVES I Determine the toxicity associated with repeated vaccination with recombinant vaccinia DF3MUC1 vaccine rV-DF3MUC1 in patients with metastatic breast cancer II Determine the maximum tolerated dose of rV-DF3MUC1 based on cellular and humoral immunity in these patients III Determine whether vaccination with rV-DF3MUC1 is associated with antitumor activity in these patients
OUTLINE This is an open label dose escalation study Patients receive recombinant vaccinia DF3MUC1 vaccine rV-DF3MUC1 intradermally Treatment repeats every month for 3 courses in the absence of disease progression or unacceptable toxicity Cohorts of at least 6 patients receive escalating doses of rV-DF3MUC1 until the maximum tolerated dose MTD or the highest dose level to be tested is reached The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity Patients are followed monthly for 6 months
PROJECTED ACCRUAL A total of 16-28 patients will be accrued for this study within 1-2 years
OUTLINE This is an open label dose escalation study Patients receive recombinant vaccinia DF3MUC1 vaccine rV-DF3MUC1 intradermally Treatment repeats every month for 3 courses in the absence of disease progression or unacceptable toxicity Cohorts of at least 6 patients receive escalating doses of rV-DF3MUC1 until the maximum tolerated dose MTD or the highest dose level to be tested is reached The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity Patients are followed monthly for 6 months
PROJECTED ACCRUAL A total of 16-28 patients will be accrued for this study within 1-2 years
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-T98-0057 | OTHER | Protocol relative to DFPCC 97-050 | httpsreporternihgovquickSearchP30CA006516 |
| U01CA062490 | NIH | None | None |
| P30CA006516 | NIH | None | None |