NCT00020254

Brief Summary

RATIONALE: Vaccines made from prostate cancer cells may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Interleukin-2 may stimulate a person's white blood cells to kill prostate cancer cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using nilutamide may fight prostate cancer by reducing the production of androgens. It is not yet known which treatment regimen is more effective for treating prostate cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy plus sargramostim and interleukin-2 with that of nilutamide alone in treating patients who have prostate cancer that has not responded to hormone therapy.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
Last Updated

April 29, 2015

Status Verified

April 1, 2003

Enrollment Period

4.3 years

First QC Date

July 11, 2001

Last Update Submit

April 28, 2015

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostaterecurrent prostate cancer

Interventions

aldesleukinBIOLOGICAL
recombinant fowlpox-prostate specific antigen vaccineBIOLOGICAL
recombinant vaccinia prostate-specific antigen vaccineBIOLOGICAL
recombinant vaccinia-B7.1 vaccineBIOLOGICAL
sargramostimBIOLOGICAL
nilutamideDRUG

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed hormone-refractory adenocarcinoma of the prostate * Rising PSA after orchiectomy and/or while receiving at least 1 regimen of luteinizing hormone-releasing hormone (LHRH) * PSA must have risen at least 0.5 ng/mL from baseline on 2 successive measurements during and/or after hormonal therapy * PSA greater than 1.0 ng/mL * If on antiandrogen therapy, must undergo antiandrogen withdrawal for at least 6 weeks and still have evidence of rising PSA * After prior bicalutamide, must undergo withdrawal for at least 6 weeks and still have evidence of rising PSA * Testosterone no greater than 50 ng/mL if no prior orchiectomy * No metastatic disease by bone scan and CT scan or MRI of the abdomen and pelvis and by CT scan or x-ray of the chest * No active or prior CNS metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod 0-2 OR * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute lymphocyte count at least 600/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 8.0 g/dL Hepatic: * Bilirubin no greater than 1.6 mg/dL * AST and ALT no greater than 4 times normal Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance greater than 60 mL/min * Urinalysis normal OR * Proteinuria no greater than 1 g/24-hour urine collection * No hematuria or abnormal sediment unless underlying cause is nonrenal Immunologic: * HIV negative * No altered immune function * No autoimmune disease, including the following: * Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia * Systemic lupus erythematosus, Sjogren's syndrome, or scleroderma * Myasthenia gravis * Goodpasture syndrome * Addison's disease, Hashimoto's thyroiditis, or active Graves' disease * No known allergy or untoward reaction to prior vaccination with vaccinia virus * No known allergy to eggs * No active or prior eczema or other eczematoid skin disorders * No other acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, impetigo, varicella zoster, burns, severe acne, or other open rashes or wounds) Other: * No other serious concurrent illness * No active infections within the past 3 days * No history of seizures, encephalitis, or multiple sclerosis * No close or household contact for at least 2 weeks after each vaccinia virus inoculation with the following high-risk individuals: * Children under 5 years of age * Pregnant or nursing women * Individuals with active or prior eczema or other eczematoid skin disorders, atopic dermatitis, impetigo, varicella zoster, burns, severe acne, or other open rashes or wounds * Immunosuppressed or immunodeficient (by disease or therapy) individuals, including those with HIV infection * No other malignancy within the past 3 years except squamous cell or basal cell skin cancer or other curatively treated malignancy PRIOR CONCURRENT THERAPY: Biologic therapy: * Must have prior vaccinia for smallpox immunization * No other concurrent biologic therapy Chemotherapy: * No prior chemotherapy for prostate cancer * No concurrent chemotherapy Endocrine therapy: * See Disease Characteristics * At least 4 weeks since prior hormonal therapy (6 weeks for bicalutamide) and recovered * If disease progression on LHRH antagonist, must continue to receive that LHRH agent or undergo surgical castration * No concurrent steroids unless topical or inhaled * No other concurrent hormonal therapy Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered * No prior radiotherapy to more than 50% of nodal groups * No concurrent radiotherapy Surgery: * See Disease Characteristics * See Endocrine therapy * At least 4 weeks since prior surgery and recovered * No prior splenectomy Other: * No concurrent homeopathic therapy with PC-SPES or genistein

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Related Publications (5)

  • Tsang KY, Zhu M, Even J, Gulley J, Arlen P, Schlom J. The infection of human dendritic cells with recombinant avipox vectors expressing a costimulatory molecule transgene (CD80) to enhance the activation of antigen-specific cytolytic T cells. Cancer Res. 2001 Oct 15;61(20):7568-76.

    PMID: 11606396BACKGROUND

  • Madan RA, Gulley JL, Schlom J, Steinberg SM, Liewehr DJ, Dahut WL, Arlen PM. Analysis of overall survival in patients with nonmetastatic castration-resistant prostate cancer treated with vaccine, nilutamide, and combination therapy. Clin Cancer Res. 2008 Jul 15;14(14):4526-31. doi: 10.1158/1078-0432.CCR-07-5048.

    PMID: 18628467RESULT

  • Arlen PM, Gulley JL, Todd N, Lieberman R, Steinberg SM, Morin S, Bastian A, Marte J, Tsang KY, Beetham P, Grosenbach DW, Schlom J, Dahut W. Antiandrogen, vaccine and combination therapy in patients with nonmetastatic hormone refractory prostate cancer. J Urol. 2005 Aug;174(2):539-46. doi: 10.1097/01.ju.0000165159.33772.5b.

    PMID: 16006888RESULT

  • Arlen PM, Gulley JL, Novik L, et al.: A randomized phase II trial of either vaccine therapy (recombinant pox viruses expressing PSA and the B7.1 costimulatory molecule) versus hormone therapy (nilutamide) in patients with hormone refractory prostate cancer and no radiographic evidence of disease. [Abstract] J Urol 169 (4 Suppl): A-941, 243, 2003.

    RESULT

  • Arlen PM, Gulley J, Novik L, et al.: A randomized phase II trial of either vaccine therapy (recombinant pox viruses expressing PSA and the B7.1 costimulatory molecule) versus hormone therapy (nilutamide) in patients (pts) with hormone refractory prostate cancer and no radiographic evidence of disease. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-728, 2002.

    RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

aldesleukinPROSTVACsargramostimnilutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Philip M. Arlen, MD

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

June 1, 2000

Primary Completion

October 1, 2004

Last Updated

April 29, 2015

Record last verified: 2003-04

Locations

US(1)