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Vaccine Therapy in Treating Patients With Advanced Adenocarcinoma of the Prostate (Prostate Cancer)

Primary Purpose

Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IV Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
recombinant fowlpox-prostate specific antigen vaccine
recombinant vaccinia prostate-specific antigen vaccine
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Prostate

Eligibility Criteria

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

Inclusion Criteria: Histologically proven adenocarcinoma of the prostate with evidence of metastatic disease including any of the following: Lymph node positive and prostate-specific antigen (PSA) at least 10 ng/mL Bone scan positive and PSA at least 10 ng/mL Prior radical prostatectomy with rising PSA and PSA at least 2 ng/mL Prior radiotherapy and PSA at least 10 ng/mL Prior cryosurgery and PSA at least 10 ng/mL PSA criteria does not apply to patients who are assigned to group B of this study and were previously treated on vaccine trial DFCI-96079 No symptomatic metastatic disease (no bony pain) Complete HLA typing required Performance status - ECOG 0 or 1 WBC greater than 2,000/mm^3 Platelet count greater than 100,000/mm^3 Bilirubin less than 2.0 mg/dL SGPT less than 4 times upper limit of normal Creatinine less than 4.0 mg/dL No altered immune function such as eczema No autoimmune diseases such as the following: Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia Systemic lupus erythematosus, Sjögren's syndrome, or scleroderma Myasthenia gravis Goodpasture's syndrome Addison's disease, Hashimoto's thyroiditis, or active Graves' disease HIV negative No allergy or untoward reaction to prior vaccinia (smallpox) vaccination No hypersensitivity to eggs No prior or concurrent extensive eczema or skin disorders (e.g., extensive psoriasis, burns, impetigo, or disseminated zoster) No other concurrent serious illness No active infection requiring antibiotics until infection has cleared and antibiotics have been stopped for at least 3 days Fertile patients must use effective contraception No close contact or household contact with the following high-risk individuals for at least 2 weeks after each vaccination: Children under age 5 Pregnant or nursing women Individuals with prior or concurrent extensive eczema or other eczematoid skin disorders Individuals with other acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds) Immunodeficient or immunosuppressed individuals (by disease or therapy) such as those with HIV infection See Disease Characteristics See Endocrine therapy Prior vaccinia (smallpox) immunization required No other concurrent biologic therapy (e.g., interferon or interleukin) for cancer No prior chemotherapy for metastatic disease No concurrent anticancer chemotherapy No prior hormonal therapy for metastatic disease Prior neoadjuvant hormonal therapy followed by prostatectomy or radiotherapy allowed Patients previously treated with recombinant vaccinia-PSA vaccine may have hormonal therapy since discontinuing that treatment (Group B) No concurrent hormonal therapy or steroids See Disease Characteristics See Endocrine therapy No concurrent radiotherapy See Disease Characteristics See Endocrine therapy No prior splenectomy At least 3 days since prior antibiotics No concurrent immunosuppressive treatment (e.g., after organ transplantation)

Sites / Locations

  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I

Arm II

Arm Description

Patients receive recombinant fowlpox-PSA vaccine IM at the MTD from the safety cohort every 4 weeks for 3 courses. Patients then receive recombinant vaccinia-PSA vaccine intradermally every 4 weeks for 2 courses.

Patients receive the same vaccines as in arm I but in reverse order.

Outcomes

Primary Outcome Measures

PSA response
PSA response is assessed at 3 successive monthly determinations, starting 28 days after the final vaccine dose.

Secondary Outcome Measures

Full Information

First Posted
April 6, 2000
Last Updated
January 23, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005039
Brief Title
Vaccine Therapy in Treating Patients With Advanced Adenocarcinoma of the Prostate (Prostate Cancer)
Official Title
A Phase II Randomized Trial of Recombinant Fowlpox and Recombinant Vaccinia Virus Expressing PSA in Patients With Adenocarcinoma of the Prostate
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Administratively complete.
Study Start Date
January 2000 (undefined)
Primary Completion Date
March 2007 (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
Randomized phase II trial to determine the effectiveness of vaccine therapy in treating patients who have advanced adenocarcinoma of the prostate (prostate cancer). Vaccines made from a person's prostate cancer cells may make the body build an immune response to kill tumor cells
Detailed Description
OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of recombinant fowlpox prostate-specific antigen (PSA) vaccine in patients with advanced adenocarcinoma of the prostate. II. Determine whether vaccination with recombinant fowlpox-PSA vaccine is associated with antitumor activity in these patients. III. Determine the efficacy of prime and boost regimens using recombinant fowlpox-PSA vaccine and recombinant vaccinia-PSA vaccine in these patients. IV. Compare the PSA-specific T-cell response in patients treated with recombinant fowlpox-PSA vaccine followed by recombinant vaccinia-PSA vaccine vs the same vaccines but in reverse order. OUTLINE: This is a randomized, open-label, multicenter, dose-escalation study of recombinant fowlpox prostate-specific antigen (PSA) vaccine. SAFETY COHORT: The first cohort of 3 patients receives vaccination with recombinant fowlpox-PSA vaccine intramuscularly (IM). Treatment repeats every 4 weeks for 3 courses. In the absence of unacceptable toxicity in the first cohort, the second cohort of 3 patients receives the same vaccine at the dose level immediately higher than the first cohort dose level. In the presence of unacceptable toxicity in the first cohort, the second cohort of 3 patients receives the same vaccine at a dose level lower than the first cohort dose level. The maximum tolerated dose (MTD) is the dose preceding that at which 1 of 6 patients experiences grade 3 or worse dose-limiting toxicity. Subsequent patients are assigned to one of two vaccination groups based on prior treatment with recombinant vaccinia-PSA vaccine: GROUP A (no prior recombinant vaccinia-PSA vaccine): Patients are randomized to one of two vaccination arms: ARM I: Patients receive recombinant fowlpox-PSA vaccine IM at the MTD from the safety cohort every 4 weeks for 3 courses. Patients then receive recombinant vaccinia-PSA vaccine intradermally every 4 weeks for 2 courses. ARM II: Patients receive the same vaccines as in arm I but in reverse order. GROUP B (prior recombinant vaccinia-PSA vaccine): Patients receive treatment as in arm I, group A. GROUPS A AND B: Patients with stable or responding disease at 6 months after completion of vaccination therapy may continue treatment on the group and arm to which they were originally assigned. Treatment repeats every 6-9 months in the absence of disease progression. Patients are followed monthly for 6 months and then every 3 months thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IV Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive recombinant fowlpox-PSA vaccine IM at the MTD from the safety cohort every 4 weeks for 3 courses. Patients then receive recombinant vaccinia-PSA vaccine intradermally every 4 weeks for 2 courses.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients receive the same vaccines as in arm I but in reverse order.
Intervention Type
Biological
Intervention Name(s)
recombinant fowlpox-prostate specific antigen vaccine
Other Intervention Name(s)
fowlpox-PSA vaccine, recombinant fowlpox-PSA vaccine, rF-PSA
Intervention Description
Given IM
Intervention Type
Biological
Intervention Name(s)
recombinant vaccinia prostate-specific antigen vaccine
Other Intervention Name(s)
Prostate Specific Antigen Expressing Vaccinia Virus Vaccine, rV-PSA vaccine, vaccinia prostate-specific antigen vaccine, vaccinia-prostate-specific antigen vaccine, VPSA
Intervention Description
Given intradermally
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
PSA response
Description
PSA response is assessed at 3 successive monthly determinations, starting 28 days after the final vaccine dose.
Time Frame
Up to 3 months after the final vaccine dose

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven adenocarcinoma of the prostate with evidence of metastatic disease including any of the following: Lymph node positive and prostate-specific antigen (PSA) at least 10 ng/mL Bone scan positive and PSA at least 10 ng/mL Prior radical prostatectomy with rising PSA and PSA at least 2 ng/mL Prior radiotherapy and PSA at least 10 ng/mL Prior cryosurgery and PSA at least 10 ng/mL PSA criteria does not apply to patients who are assigned to group B of this study and were previously treated on vaccine trial DFCI-96079 No symptomatic metastatic disease (no bony pain) Complete HLA typing required Performance status - ECOG 0 or 1 WBC greater than 2,000/mm^3 Platelet count greater than 100,000/mm^3 Bilirubin less than 2.0 mg/dL SGPT less than 4 times upper limit of normal Creatinine less than 4.0 mg/dL No altered immune function such as eczema No autoimmune diseases such as the following: Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia Systemic lupus erythematosus, Sjögren's syndrome, or scleroderma Myasthenia gravis Goodpasture's syndrome Addison's disease, Hashimoto's thyroiditis, or active Graves' disease HIV negative No allergy or untoward reaction to prior vaccinia (smallpox) vaccination No hypersensitivity to eggs No prior or concurrent extensive eczema or skin disorders (e.g., extensive psoriasis, burns, impetigo, or disseminated zoster) No other concurrent serious illness No active infection requiring antibiotics until infection has cleared and antibiotics have been stopped for at least 3 days Fertile patients must use effective contraception No close contact or household contact with the following high-risk individuals for at least 2 weeks after each vaccination: Children under age 5 Pregnant or nursing women Individuals with prior or concurrent extensive eczema or other eczematoid skin disorders Individuals with other acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds) Immunodeficient or immunosuppressed individuals (by disease or therapy) such as those with HIV infection See Disease Characteristics See Endocrine therapy Prior vaccinia (smallpox) immunization required No other concurrent biologic therapy (e.g., interferon or interleukin) for cancer No prior chemotherapy for metastatic disease No concurrent anticancer chemotherapy No prior hormonal therapy for metastatic disease Prior neoadjuvant hormonal therapy followed by prostatectomy or radiotherapy allowed Patients previously treated with recombinant vaccinia-PSA vaccine may have hormonal therapy since discontinuing that treatment (Group B) No concurrent hormonal therapy or steroids See Disease Characteristics See Endocrine therapy No concurrent radiotherapy See Disease Characteristics See Endocrine therapy No prior splenectomy At least 3 days since prior antibiotics No concurrent immunosuppressive treatment (e.g., after organ transplantation)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Paul Eder
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Vaccine Therapy in Treating Patients With Advanced Adenocarcinoma of the Prostate (Prostate Cancer)

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