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Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
recombinant viral vaccine therapy
sargramostim
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital Cancer Center
  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 10, 1999
Last Updated
February 8, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004029
Brief Title
Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer
Official Title
A PHASE I TRIAL OF RECOMBINANT VACCINIA VIRUS THAT EXPRESSES PSA IN PATIENTS WITH ADENOCARCINOMA OF THE PROSTATE
Study Type
Interventional

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
December 1996 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: I. Assess the toxicity associated with repeated vaccination with recombinant vaccinia virus expressing prostate-specific antigen (rV-PSA) in patients with metastatic adenocarcinoma of the prostate. II. Determine the optimal dose of rV-PSA given at monthly intervals based on cellular and hormonal immunity. III. Determine whether vaccination with rV-PSA is associated with anti-tumor activity. IV. Determine whether granulocyte-macrophage colony-stimulating factor (GM-CSF) has an effect on cellular and humoral immunity different from rV-PSA, and whether the addition of GM-CSF has enhanced antitumor effect compared to rV-PSA alone. OUTLINE: This is an open label, dose escalation study. Patients 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. Patients are followed monthly for 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
recombinant viral vaccine therapy
Intervention Type
Biological
Intervention Name(s)
sargramostim

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald W. Kufe, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result

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Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer

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