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RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
- Determine the toxicity of vaccination comprising recombinant vaccinia-MUC-1 and recombinant vaccinia-TRICOM vaccine in patients with metastatic breast cancer.
- Determine the maximum tolerated dose of this regimen in these patients.
- Determine the toxicity of this regimen when administered with sargramostim (GM-CSF) in these patients.
- Determine the host immune reactivity in patients treated with this regimen with or without GM-CSF.
- Determine the antitumor activity in patients treated with this regimen with or without GM-CSF.
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.
Masking: Open Label, Primary Purpose: Treatment
recombinant vaccinia-MUC-1 vaccine, recombinant vaccinia-TRICOM vaccine, sargramostim
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:54:47-0400
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Combining colony-stimulating factors such as sargramostim with vaccines may kill more tumor cells. ...
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow...
RATIONALE: Vaccines made from a gene-modified virus may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number ...
RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Biological therapies, such as MDX-010 and GM-CSF, may stimulat...
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Porcine reproductive and respiratory syndrome (PRRS) is almost always caused by the North American strain of PRRS virus (PRRSV) in China; the European genotype of PRRSV has emerged in China. The mixed...
In 2002, the United States implemented a new program for smallpox vaccinations among military personnel using a live vaccinia virus product. Approximately 2.4 million US military service members and h...
Modified Vaccinia Ankara (MVA) is a live, viral vaccine under advanced development as a non-replicating smallpox vaccine. A randomised, double-blind, placebo-controlled phase III clinical trial was co...
Smallpox, or vaccinia, has been eradicated worldwide as a disease; however, it may be weaponized and is thus a required immunization when military members deploy to certain parts of the world.
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A live VACCINIA VIRUS vaccine of calf lymph or chick embryo origin, used for immunization against smallpox. It is now recommended only for laboratory workers exposed to smallpox virus. Certain countries continue to vaccinate those in the military service. Complications that result from smallpox vaccination include vaccinia, secondary bacterial infections, and encephalomyelitis. (Dorland, 28th ed)
The type species of ORTHOPOXVIRUS, related to COWPOX VIRUS, but whose true origin is unknown. It has been used as a live vaccine against SMALLPOX. It is also used as a vector for inserting foreign DNA into animals. Rabbitpox virus is a subspecies of VACCINIA VIRUS.
The cutaneous and occasional systemic reactions associated with vaccination using smallpox (variola) vaccine.
A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.
A live vaccine containing attenuated poliovirus, types I, II, and III, grown in monkey kidney cell tissue culture, used for routine immunization of children against polio. This vaccine induces long-lasting intestinal and humoral immunity. Killed vaccine induces only humoral immunity. Oral poliovirus vaccine should not be administered to immunocompromised individuals or their household contacts. (Dorland, 28th ed)
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...