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Docetaxel and Prednisone With or Without Vaccine Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

2014-08-27 03:12:50 | BioPortfolio

Summary

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.

Description

OBJECTIVES:

Primary

- 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.

Secondary

- 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.

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Conditions

Prostate Cancer

Intervention

fowlpox-PSA-TRICOM vaccine, vaccinia-PSA-TRICOM vaccine, docetaxel, prednisone

Status

Not yet recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:50-0400

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Medical and Biotech [MESH] Definitions

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.

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