Track topics on Twitter Track topics that are important to you
RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, 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 an antigen may help the body build an effective immune response to kill tumor cells. It is not yet known giving docetaxel and prednisone together is more effective with or without vaccine therapy in treating prostate cancer.
PURPOSE: This randomized phase II trial is studying giving docetaxel and prednisone together with or without vaccine therapy to see how well it works in treating patients with metastatic hormone-resistant prostate cancer.
- To evaluate the overall survival of patients with castrate-resistant, metastatic prostate cancer treated with docetaxel and prednisone with versus without vaccine therapy comprising vaccinia-PSA(L155)-TRICOM and fowlpox-PSA(L155)-TRICOM.
- To evaluate the time to radiographic progression in patients treated with these regimens.
- To compare objective response of patients with measurable disease treated with these regimens.
- To evaluate prostate-specific antigen (PSA) response rates (decline ≥ 50%) in patients treated with these regimens.
- To evaluate immune response elicited in patients before and after docetaxel chemotherapy.
- To evaluate the association between development of PSA-specific immune responses, time to progression, and overall survival in patients treated with these regimens.
- To evaluate the association of predicted survival (by Halabi nomogram) with actual survival of patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to disease progression (PSA vs radiographic criteria), extraskeletal metastases (yes vs no), and prior bisphosphonate (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I (vaccine and chemotherapy): Patients receive vaccinia-PSA(L155)-TRICOM vaccine subcutaneously (SC) on day 1 of course 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15, 29, 43, and 57 of course 1. Beginning on day 85 (day 1 of course 2), patients receive docetaxel IV over 1 hour on day 1 and oral prednisone twice daily on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
- Arm II (chemotherapy): Patients receive docetaxel IV over 1 hour on day 1 and oral prednisone twice daily on days 1-21. Treatment with repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Some patients undergo blood sample collection to measure frequency of PSA-specific T-cells and other biomarkers of immune response.
After completion of study therapy, patients are followed up every 3-6 months for 5 years.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
fowlpox-PSA-TRICOM vaccine, vaccinia-PSA-TRICOM vaccine, docetaxel, prednisone
Not yet recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:12:50-0400
RATIONALE: Vaccines made from a gene-modified virus may make the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune respons...
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 help the body build an effective immune response to kill tumor cells. Biological therapies, such as MDX-010 and GM-CSF, may stimulat...
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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining vaccine therapy and radiation...
Although development of an HSV vaccine is a priority there is currently no vaccine available. The recent failure of subunit vaccines suggest that presentation of more antigens via a live attenuated va...
The widespread use of pneumococcal conjugate vaccine (PCV) has brought about a dramatic decrease in pneumococci of vaccine serotypes (VT) but non-vaccine serotypes (NVT) have emerged. Robust data on V...
I propose that influenza vaccine failure be defined as receipt of a properly stored and administered vaccine with the subsequent development of documented influenza. Several mechanisms of vaccine fail...
Recent serogroup C meningococcal disease outbreaks led to meningococcal vaccine recommendations for Southern California men who have sex with men (MSM). Assessment of vaccine confidence is critical to...
To outline the need for a new tuberculosis (TB) vaccine; challenges for induction of vaccine-mediated protection in HIV-infected persons; and recent advances in clinical development.
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)
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)
A bacterial vaccine for the prevention of brucellosis in man and animal. Brucella abortus vaccine is used for the immunization of cattle, sheep, and goats.
A live attenuated virus vaccine of chick embryo origin, used for routine immunization of children and for immunization of adolescents and adults who have not had mumps or been immunized with live mumps vaccine. Children are usually immunized with measles-mumps-rubella combination vaccine.
Prostate cancer (cancer de prostata) Prostate cancer (cancer de prostata) is a form of cancer that develops in the prostate, a gland in the male reproductive system. Most prostate cancers are slow growing; however, there are cases of aggressive prostat...
An antibody is a protein produced by the body's immune system when it detects harmful substances, called antigens. Examples of antigens include microorganisms (such as bacteria, fungi, parasites, and viruses) and chemicals. Antibodies may be produc...