Trials / Withdrawn
WithdrawnNCT00706615
Vaccine Therapy in Treating Women With Previously Treated Metastatic Breast Cancer
A Single Arm Open-Label Phase I Study of An Injectable Replication-Incompetent Adenoviral Vector Vaccine Used to Produce An Immune Response to MUC-1 Positive Epithelial Cancer Cells in Metastatic Breast Cancer
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Jonsson Comprehensive Cancer Center · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating women with previously treated metastatic breast cancer.
Detailed description
OBJECTIVES: Primary * Characterize the safety profile of Ad-sig-hMUC-1/ecdCD40L vaccine in women with metastatic breast cancer. * Identify a tolerable, immunologically active dose level of this vaccine in these patients. Secondary * Evaluate the immune function in these patients before and after treatment with this vaccine. OUTLINE: Patients receive MUC-1 vector vaccine subcutaneously on day 0. After completion of study treatment, patients are followed monthly for 9 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Ad-sig-hMUC-1/ecdCD40L vaccine |
Timeline
- Start date
- 2008-07-01
- Primary completion
- 2009-04-01
- First posted
- 2008-06-27
- Last updated
- 2020-07-31
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00706615. Inclusion in this directory is not an endorsement.