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Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00071942 |
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with metastatic breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: recombinant vaccinia-MUC-1 vaccine Drug: recombinant vaccinia-TRICOM vaccine Drug: sargramostim |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I Trial of an Admixture of Recombinant Vaccinia Virus That Express DF3/MUC1 and rV-TRICOM (B7.ICAM-1, and LFA-3) in Patients With Metastatic Adenocarcinoma of the Breast |
Estimated Enrollment: | 22 |
Study Start Date: | October 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, dose-escalation study.
Patients receive vaccination comprising recombinant vaccinia-MUC-1 and recombinant vaccinia-TRICOM vaccine intradermally on days 1 and 29 (for a total of 2 doses) in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of recombinant vaccinia-MUC-1 and recombinant vaccinia-TRICOM vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 10 patients (including 5 HLA-A2-positive patients) receive vaccination as above at the MTD and sargramostim (GM-CSF) subcutaneously on days 1-4 and 29-32.
Patients are followed at 4 weeks, monthly until disease progression, and then annually for up to 15 years.
PROJECTED ACCRUAL: A total of 11-22 patients will be accrued for this study within 18-24 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Immunologic
Other
Must be able to avoid close household contact with any of the following individuals for at least 3 weeks after study vaccination:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent steroid therapy
Radiotherapy
Surgery
Other
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Joseph Paul Eder, MD | Dana-Farber Cancer Institute |
Study ID Numbers: | CDR0000335472, DFCI-02310, NCI-5747 |
Study First Received: | November 4, 2003 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00071942 |
Health Authority: | United States: Food and Drug Administration |
stage IV breast cancer male breast cancer recurrent breast cancer |
Virus Diseases Metronidazole Skin Diseases Breast Neoplasms, Male Vaccinia |
Breast Neoplasms Adenocarcinoma Breast Diseases Recurrence |
Neoplasms Neoplasms by Site |