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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00217750 |
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vaccines made from a gene-modified virus may help the body build an immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of white blood cells found in bone marrow or peripheral blood. GM-CSF may also help the vaccine work better. It is not yet known whether giving docetaxel together with vaccine therapy and GM-CSF is more effective than docetaxel alone in treating metastatic breast cancer.
PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with vaccine therapy and GM-CSF works compared to docetaxel alone in treating patients with metastatic breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: docetaxel Drug: falimarev Drug: inalimarev Drug: sargramostim |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Pilot Phase II Study of Docetaxel Alone or in Combination With PANVAC™ -V (Vaccinia) and PANVAC™-F (Fowlpox) in Adults With Metastatic Breast Cancer |
Estimated Enrollment: | 48 |
Study Start Date: | September 2005 |
Estimated Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm I: Experimental
Patients receive vaccinia-CEA-MUC-1-TRICOM vaccine subcutaneously (SC) once and sargramostim (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel IV over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.
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Drug: docetaxel
given IV
Drug: falimarev
given subcutaneously
Drug: inalimarev
given subcutaneously
Drug: sargramostim
given subcutaneously
|
Arm II: Experimental
Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-CEA-MUC-1-TRICOM vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and GM-CSF as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.
|
Drug: docetaxel
given IV
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, controlled, pilot study. HER-2 positive patients are stratified according to concurrent trastuzumab (Herceptin®) therapy (yes or no). Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed annually for 15 years.
PROJECTED ACCRUAL: A total of 48 patients (24 per treatment arm) will be accrued for this study within 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the breast
HLA-A2 phenotype known
HER2/neu status known
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Meets 1 of the following criteria:
Renal
Cardiovascular
No cardiac complications including any of the following:
Gastrointestinal
Immunologic
No altered immune function, including any of the following conditions:
Other
No close household contact (i.e., shares housing or has close physical contact) with the following individuals within 2 weeks after vaccinia vaccination:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
At least 12 months since prior adjuvant docetaxel
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Principal Investigator: | James Gulley, MD, PhD | National Cancer Institute (NCI) |
Study ID Numbers: | CDR0000442407, NCI-05-C-0229, NCI-6977 |
Study First Received: | September 20, 2005 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00217750 |
Health Authority: | Unspecified |
male breast cancer recurrent breast cancer stage IV breast cancer |
Docetaxel Skin Diseases Breast Neoplasms, Male Vaccinia |
Breast Neoplasms Breast Diseases Recurrence |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |