Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer

NCT00004029 | Completed Phase 1

• 3 other identifiers: CDR0000065275DFCI-96079NCI-T95-0086H
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 3

Brief Summary

Phase I trial to study the effectiveness of vaccine therapy in treating patients with metastatic prostate cancer. Vaccines may make the body build an immune response to kill tumor cells.

Conditions

Prostate Cancer

Keywords

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

Study Arms (1)

Arm I

EXPERIMENTAL

atients in cohorts of 3-6 receive 3 vaccinations with rV-PSA at 4-week intervals (days 1, 29, 57, and 85) in the absence of disease progression or unacceptable toxicity. Response assessment is performed at eight weeks. Patients who discontinue therapy prior to eight weeks are considered unevaluable for response. If dose limiting toxicity is observed in 2 of 6 patients entered at a dose level, no further patients are entered at that level and the MTD is defined as the preceding dose level. Ten additional patients are treated at the MTD and receive granulocyte-macrophage colony-stimulating factor (GM-CSF) administered subcutaneously on day -1 through day 2 of each cycle. Patients who are HLA-A2 positive, have received all 3 rV-PSA vaccinations without unacceptable toxicity, and have been off study for at least 30 days due to disease progression may continue treatment with rV-PSA at the highest dose level and the addition of GM-CSF.

Biological: recombinant viral vaccine therapy; Biological: sargramostim

Interventions

recombinant viral vaccine therapy BIOLOGICAL

Arm I

sargramostim BIOLOGICAL

Arm I

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically proven adenocarcinoma of the prostate with evidence of metastatic disease based on any of the following: * Lymph node positive and PSA at least 10 ng/mL * Bone scan positive and PSA at least 10 ng/mL * PSA at least 2 ng/mL and rising following radical prostatectomy * PSA at least 10 ng/mL following radiotherapy * No symptomatic metastatic disease (bony pain) PATIENT CHARACTERISTICS: * Age: 18 and over * Performance status: ECOG 0 or 1 * WBC greater than 2,000/mm3 * Platelet count greater than 100,000/mm3 * Bilirubin less than 2.0 mg/dL * AST less than 4 times normal * Creatinine less than 2.0 mg/dL * Must be type HLA-A2 Prior vaccinia (smallpox) exposure required * At least normal delayed type hypersensitivity to mumps and Candida * At least normal CD4:CD8 ratio (greater than 1) * At least normal lymphocyte proliferation testing (to Con A) * At least normal immunoglobulin levels * No evidence of altered immune responsiveness or autoimmune syndromes (e.g., scleroderma, systemic lupus erythematosus) * No HIV antibody No prior splenectomy * No known allergy to eggs * No active extensive skin disorders (e.g, psoriasis, burns, impetigo, disseminated zoster) * No other serious intercurrent illness * No active infections unless cleared and at least 3 days since antibiotic therapy * No close contact for 2 weeks after each vaccination with the following people: * Children less than 3 years old * Pregnant women * Individuals with eczema or skin conditions listed above * Immunosuppressed individuals PRIOR CONCURRENT THERAPY: * No concurrent biologic therapy * No prior chemotherapy for metastatic disease * No prior hormone therapy for metastatic disease * Neoadjuvant hormone therapy prior to prostatectomy or radiotherapy allowed * No concurrent steroids or hormonal medications * Prior radiotherapy allowed * Prior surgery allowed

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 (3)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• Eder JP Jr, Kantoff PW, Bubley GJ, et al.: A phase I trial of recombinant prostate specific antigen expressing vaccinia virus vaccine, PROSTVAC (rV-PSA) in advanced prostate cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A1692, 439, 1999.

  RESULT

• Eder JP Jr, Kantoff PW, Bubley GJ, et al.: A phase I trial of recombinant vaccinia virus, PROSTVAC that expresses prostate specific antigen (rV-PSA) as a vaccine in men with advanced prostate cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A1672, 434, 1998.

  RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

sargramostim

Condition Hierarchy (Ancestors)

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

Study Officials

• Donald W. Kufe, MD

  Dana-Farber Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 1999
• First Posted: August 30, 2004
• Study Start: December 1, 1996
• Primary Completion: May 1, 2006
• Last Updated: February 11, 2013

Record last verified: 2006-06

Locations

US (3)