Adenocarcinoma of the ProstatePhase 2NCT00005039
Vaccine Therapy in Treating Patients With Advanced Adenocarcinoma of the Prostate (Prostate Cancer)
A Phase 2 study testing recombinant fowlpox-prostate specific antigen vaccine, recombinant vaccinia prostate-specific antigen vaccine and laboratory biomarker analysis in people with Adenocarcinoma of the Prostate and Recurrent Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IV Prostate Cancer
- What is being tested?
- recombinant fowlpox-prostate specific antigen vaccine, recombinant vaccinia prostate-specific antigen vaccine and laboratory biomarker analysis
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2000to Mar 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase II Randomized Trial of Recombinant Fowlpox and Recombinant Vaccinia Virus Expressing PSA in Patients With Adenocarcinoma of the Prostate
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
Read the detailed description
OBJECTIVES:
- 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.
- Being tested
- recombinant fowlpox-prostate specific antigen vaccine, recombinant vaccinia prostate-specific antigen vaccine, laboratory biomarker analysis
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant fowlpox-prostate specific antigen vaccineBiological
Also called fowlpox-PSA vaccine, recombinant fowlpox-PSA vaccine, rF-PSA
Given IM
recombinant vaccinia prostate-specific antigen vaccineBiological
Also called Prostate Specific Antigen Expressing Vaccinia Virus Vaccine, rV-PSA vaccine, vaccinia prostate-specific antigen vaccine, vaccinia-prostate-specific antigen vaccine
Given intradermally
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | 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. Receives: Biological: recombinant fowlpox-prostate specific antigen vaccine; Biological: recombinant vaccinia prostate-specific antigen vaccine; Other: laboratory biomarker analysis |
| Arm II | Experimental | Patients receive the same vaccines as in arm I but in reverse order. Receives: Biological: recombinant fowlpox-prostate specific antigen vaccine; Biological: recombinant vaccinia prostate-specific antigen vaccine; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA response
PSA response is assessed at 3 successive monthly determinations, starting 28 days after the final vaccine dose.
Measured: Up to 3 months after the final vaccine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJan 2000
- Primary completionMar 2007
Why it stopped: Administratively complete.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Joseph Paul Eder, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005039
- Sponsor's protocol ID
- NCI-2012-02319
- Other IDs
- DFHCC 98-262, U01CA062490, CDR0000067630
- Status last verified
- Jan 2013
- First submitted
- 6 Apr 2000
- Last updated
- 24 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Trial of Recombinant Fowlpox and Recombinant Vaccinia Virus Expressing PSA in Patients With Adenocarcinoma of the Prostate
- ClinicalTrials.gov ID
- NCT00005039
- Acronym / sponsor ID
- NCI-2012-02319
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administratively complete.
- Enrolment
- 86 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jan 2000
- Primary completion
- Mar 2007 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Biological: recombinant fowlpox-prostate specific antigen vaccine, Biological: recombinant vaccinia prostate-specific antigen vaccine, Other: laboratory biomarker analysisPatients 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 | Experimental | Biological: recombinant fowlpox-prostate specific antigen vaccine, Biological: recombinant vaccinia prostate-specific antigen vaccine, Other: laboratory biomarker analysisPatients receive the same vaccines as in arm I but in reverse order. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (53 listed)
- Histologically proven adenocarcinoma of the prostate with evidence of metastatic disease including any of the following:
- No symptomatic metastatic disease (no bony pain)
- Complete HLA typing required
- Performance status - ECOG 0 or 1
- WBC greater than 2,000/mm^3
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant fowlpox-prostate specific antigen vaccineAlso: fowlpox-PSA vaccine, recombinant fowlpox-PSA vaccine, rF-PSAGiven IM | Biological | Arm I, Arm II |
| recombinant vaccinia prostate-specific antigen vaccineAlso: Prostate Specific Antigen Expressing Vaccinia Virus Vaccine, rV-PSA vaccine, vaccinia prostate-specific antigen vaccine, vaccinia-prostate-specific antigen vaccineGiven intradermally | Biological | Arm I, Arm II |
| laboratory biomarker analysisCorrelative studies | Other | Arm I, Arm II |
Primary outcome
PSA response
Time frame: Up to 3 months after the final vaccine dose
PSA response is assessed at 3 successive monthly determinations, starting 28 days after the final vaccine dose.
Results and safety
The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Paul Eder principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing recombinant fowlpox-prostate specific antigen vaccine, recombinant vaccinia prostate-specific antigen vaccine and laboratory biomarker analysis in people with Adenocarcinoma of the Prostate and Recurrent Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 53 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA response (time frame: Up to 3 months after the final vaccine dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.