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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-02-C-0218 | |||
| NCI-5319 |
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RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with chemotherapy may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy with or without docetaxel in treating patients who have metastatic prostate cancer.
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms after receiving priming vaccinations.
PROJECTED ACCRUAL: A total of 28 patients (14 per treatment arm) will be accrued for this study within 9-10 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant fowlpox-prostate specific antigen vaccine | Biological | |||
| recombinant vaccinia prostate-specific antigen vaccine | Biological | |||
| recombinant vaccinia-B7.1 vaccine | Biological | |||
| sargramostim | Biological | |||
| docetaxel | Drug |
DISEASE CHARACTERISTICS:
Diagnosis of androgen-independent metastatic adenocarcinoma of the prostate, confirmed by 1 of the following:
Castrate levels of testosterone with progressive disease by at least 1 of the following parameters:
2 consecutively rising prostate-specific antigen levels, separated by at least 1 week, with at least 1 measurement that is 50% above the nadir reached after the last therapeutic maneuver (must be at least 5 ng/mL)
At least 1 new metastatic deposit on technetium Tc 99 bone scintigraphy
Progression of soft-tissue metastases by imaging or palpation, as indicated by:
Serum testosterone less than 50 ng/dL if no prior surgical castration
HLA-A2 positive
No brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
No prior allergy or untoward reaction to vaccinia virus vaccination
No altered immune function, including:
Eczema
Atopic dermatitis
HIV
Autoimmune disease
No extensive psoriasis, severe acneiform rash, impetigo, varicella zoster, burns, or other traumatic or pruritic skin condition
No known allergy to eggs
Other
No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the bladder
No other life-threatening or serious illness
No unhealed surgical scars
No household or close physical contact with persons with any of the following conditions during or for 2 weeks after study treatment:
No history of seizures or encephalitis
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Philip M. Arlen, MD | National Cancer Institute (NCI) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda | Maryland | 20892-1182 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16489082 | Result | Arlen PM, Gulley JL, Parker C, Skarupa L, Pazdur M, Panicali D, Beetham P, Tsang KY, Grosenbach DW, Feldman J, Steinberg SM, Jones E, Chen C, Marte J, Schlom J, Dahut W. A randomized phase II study of concurrent docetaxel plus vaccine versus vaccine alone in metastatic androgen-independent prostate cancer. Clin Cancer Res. 2006 Feb 15;12(4):1260-9. doi: 10.1158/1078-0432.CCR-05-2059. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C588274 | PROSTVAC |
| C081222 | sargramostim |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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