Vaccine Therapy in Treating Patients With Metastatic Breast Cancer
NCT00003761 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2017-02-15
Summary
This protocol is designed to evaluate the side effects of rV-DF3/MUC1 and to determine the safest dose which should be used in the treatment of breast cancer.
Conditions
Interventions
- BIOLOGICAL
-
rV-DF3/MUC1
\- The starting dose for this Phase I study of rV-DF3/MUC1 will be 4.76 x 106 PFU. \-- Dose escalation will proceed with cohorts of at least 6 patients as follows: Per vaccination * Level 1 4.76 x 106 PFU * Level 2 4.76 x 107 PFU * Level 3 4.76 x 108 PFU
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH - lead OTHER
Principal Investigators
-
Donald W. Kufe, MD · Dana-Farber Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1999-03-03
- Primary Completion
- 2001-04-20
- Completion
- 2001-10-19
Countries
- United States
Study Locations
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