Vaccine Therapy With or Without Docetaxel in Treating Patients With Metastatic Prostate Cancer

NCT00045227 | Completed Phase 2

• 3 other identifiers: CDR0000256919NCI-02-C-0218NCI-5319
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer; stage IV prostate cancer

Interventions

recombinant fowlpox-prostate specific antigen vaccine BIOLOGICAL

recombinant vaccinia prostate-specific antigen vaccine BIOLOGICAL

recombinant vaccinia-B7.1 vaccine BIOLOGICAL

sargramostim BIOLOGICAL

docetaxel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of androgen-independent metastatic adenocarcinoma of the prostate, confirmed by 1 of the following: * Histologically confirmed disease * Pathologically documented disease and clinical course consistent with prostate cancer * 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: * Development of new area of malignant disease * At least 20% increase in sum of the longest dimension of target lesions * Serum testosterone less than 50 ng/dL if no prior surgical castration * Luteinizing hormone-releasing hormone therapy must continue * HLA-A2 positive * No brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * More than 6 months Hematopoietic * Granulocyte count at least 1,500/mm\^3 * Lymphocyte count at least 500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin less than 1.5 mg/dL * AST and ALT less than 2.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2.5 times ULN OR * Hepatic alkaline phosphatase fraction less than 2.5 times ULN Renal * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 40 mL/min * Proteinuria grade 0-1 OR * Protein less than 1,000 mg by 24-hour urine collection * No hematuria * No abnormal sediment unless non-renal Cardiovascular * No unstable or newly diagnosed angina pectoris * No myocardial infarction within the past 6 months * No New York Heart Association class II-IV congestive heart failure * No concurrent clinically significant cardiomyopathy requiring treatment Immunologic * No prior allergy or untoward reaction to vaccinia virus vaccination * No altered immune function, including: * Eczema * Atopic dermatitis * HIV * Autoimmune disease * Autoimmune neutropenia * Thrombocytopenia * Hemolytic anemia * Systemic lupus erythematosus * Sjogren's syndrome * Scleroderma * Myasthenia gravis * Goodpasture syndrome * Addison's disease * Hashimoto's thyroiditis * Active Graves' disease * Multiple sclerosis * 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: * Eczema or eczematoid skin disorders * Acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds) * Pregnant or nursing women * Children under 5 years of age * Immunodeficient or immunosuppressed (including HIV positive) individuals * No history of seizures or encephalitis PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior taxanes for metastatic prostate cancer Endocrine therapy * See Disease Characteristics * At least 4 weeks since prior flutamide * At least 6 weeks since prior bicalutamide or nilutamide * No concurrent steroids except topical steroids, inhaled steroids for mild or moderate asthma, or decadron as premedication for chemotherapy Radiotherapy * Not specified Surgery * See Disease Characteristics * No prior splenectomy Other * Recovered from prior therapy

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Related Publications (1)

• 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.

  PMID: 16489082 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

PROSTVAC; sargramostim; Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

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: September 6, 2002
• First Posted: January 27, 2003
• Study Start: August 1, 2002
• Study Completion: October 1, 2007
• Last Updated: June 19, 2013

Record last verified: 2003-12

Locations

US (1)