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Prostate CancerPhase 2NCT00003871

PSA Vaccine Therapy in Treating Patients With Advanced Prostate Cancer

A Phase 2 study testing fowlpox virus vaccine vector and recombinant vaccinia prostate-specific antigen vaccine in people with Prostate Cancer, run by Eastern Cooperative Oncology Group at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of different regimens of PSA vaccines in treating patients who have advanced prostate cancer. Read more about this study

Who is it for?
Ages 18 to 120 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
fowlpox virus vaccine vector and recombinant vaccinia prostate-specific antigen vaccine
Type of treatment
Vaccines
How many people
60 participants
Where
10 sitesUnited States
Study dates
24 Sep 1999to Jun 2002
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 to 120 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS: Histologically proven prostate cancer limited to the prostate (including seminal vesicle and/or local lymph node involvement) with elevated PSA (greater than 2 ng/ml) following surgery or rising PSA following radiotherapy Negative bone scan and CT scan of abdomen and pelvis No PSA progression during chemotherapy, hormonal therapy (including steroids), or neoadjuvant or adjuvant androgen ablation therapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 6 months Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT and SGPT no greater than 2 times upper limit of normal Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: Not specified Pulmonary: Not specified Other: No active untreated infection No known infection with HIV No concurrent medical conditions that would prevent compliance No history or evidence of active eczema or psoriasis or other contraindications to vaccinia virus administration (i.e., allergy) No significant allergy or hypersensitivity to eggs No evidence of immunosuppression Must be able to avoid contact with high risk individuals (immunosuppressed patients, children under 3, pregnant women, or patients with a history of or active eczema or other exfoliative diseases) for 7-10 days after immunization (household contacts must not be high risk) Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 6 months since prior chemotherapy and recovered Endocrine therapy: See Disease Characteristics At least 6 months since prior hormonal therapy (including steroids) and recovered Radiotherapy: See Disease Characteristics At least 3 months since prior radiotherapy of prostate and recovered Surgery: See Disease Characteristics At least 3 months since prior prostate surgery and recovered Other: Prior vaccinia immunization required OR Patient recollection of immunization and appropriate vaccination site scar

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5265

  • Veterans Affairs Medical Center - Indianapolis (Roudebush)

    Indianapolis, Indiana, 46202

  • Veterans Affairs Medical Center - Madison

    Madison, Wisconsin, 53705

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792

  • Vanderbilt Cancer Center

    Nashville, Tennessee, 37232-6838

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15213

  • Albert Einstein Comprehensive Cancer Center

    The Bronx, New York, 10461

Other trials in United States

About this study

Official title: Phase II Randomized Study of Vaccine Treatment of Advanced Prostate Cancer

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of different regimens of PSA vaccines in treating patients who have advanced prostate cancer.

Read the detailed description

OBJECTIVES: I. Evaluate the effect of prime and boost strategies using recombinant fowlpox prostate specific antigen (PSA) vaccine and recombinant vaccinia PSA vaccine on biochemical PSA progression in patients with stage D0 prostate cancer who have completed local treatment. II. Assess the tolerability and toxicity of these prime and boost treatment regimens in these patients. III. Evaluate the effects of these prime and boost treatment regimens on cellular immunity in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to HLA-2 typing (positive vs negative vs unknown). Patients are randomized to one of three treatment arms. Arm I: Patients receive intramuscular fowlpox prostate specific antigen (PSA) vaccine at weeks 0, 6, 12, and 18. Arm II: Patients receive intramuscular fowlpox PSA vaccine at weeks 0, 6, and 12 and intradermal vaccinia PSA vaccine at week 18. Arm III: Patients receive intradermal vaccinia PSA vaccine at week 0 and intramuscular fowlpox PSA vaccine at weeks 6, 12, and 18. Patients are followed at week 24, then every 3 months until year 2, every 6 months until year 5, and annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients (20 per treatment arm) will be accrued for this study.

Conditions
Prostate Cancer
Being tested
fowlpox virus vaccine vector, recombinant vaccinia prostate-specific antigen vaccine
Keywords
stage IV prostate cancer, recurrent prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fowlpox virus vaccine vectorBiological

  • recombinant vaccinia prostate-specific antigen vaccineBiological

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2004 (estimated)
  2. Study start24 Sep 1999
  3. Primary completionJun 2002

Resources

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
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003871
Sponsor's protocol ID
CDR0000067036
Other IDs
E-7897
Status last verified
Jun 2023
First submitted
1 Nov 1999
Last updated
22 Jun 2023
Results posted
No
Data monitoring committee
No

Publications

  • Kaufman HL, Wang W, Manola J, et al.: Phase II prime/boost vaccination using poxviruses expressing PSA in hormone dependent prostate cancer: follow-up clinical results from ECOG 7897. [Abstract] J Clin Oncol 23 (Suppl 16): A-4501, 378s, 2005.

  • Kaufman HL, Wang W, Manola J, DiPaola RS, Ko YJ, Sweeney C, Whiteside TL, Schlom J, Wilding G, Weiner LM. Phase II randomized study of vaccine treatment of advanced prostate cancer (E7897): a trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 2004 Jun 1;22(11):2122-32. doi: 10.1200/JCO.2004.08.083.

    PubMed 15169798

  • Kaufman HL, Wang W, Manola J, et al.: Prime/boost vaccination using poxviruses expressing PSA in D0 prostate cancer: preliminary results of ECOG 7897, a randomized phase II clinical trial. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-12, 2002.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing fowlpox virus vaccine vector and recombinant vaccinia prostate-specific antigen vaccine in people with Prostate Cancer, run by Eastern Cooperative Oncology Group at 10 sites 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?

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: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003871, which also lists 3 linked publications.

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 22 Jun 2023.

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