Vaccine Plus Booster Shots in Men With Prostate Cancer Undergoing Treatment With Radical Prostatectomy

Plain-language summary

This study evaluates the PROSTVAC vaccine and booster shots in prostate cancer patients scheduled for radical prostatectomy (surgical removal of the prostate). It included patients with confirmed prostate adenocarcinoma who were surgical candidates. It was a Phase 2 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

National Cancer Institute (NCI)

Intervention

PROSTVAC-V/TRICOM, PROSTVAC-F/TRICOM

Start date

5/31/2014

Estimated completion

1/16/2018

Countries

United States

Related genes

Locations

• Bethesda, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

-INCLUSION CRITERIA

1. Patients must have histopathological documentation of adenocarcinoma of the prostate prior to starting this study and evaluable biopsy tissue (e.g., unstained slides or blocks) available for analysis. If evaluable tissue is not available, the patient must agree to undergo a pre-vaccination prostate biopsy on study as an alternative to having available tissue available.
2. Patients must be a surgical candidate for radical prostatectomy based on standard workup of prostatic specific antigen (PSA), biopsy results, and if necessary supplemental imaging.
3. Patients must have chosen radical prostatectomy as their definitive treatment of choice for management of their prostate cancer.
4. Patients must have a performance status of 0 to 1 according to the Eastern Cooperative Oncology Group (ECOG) criteria
5. No systemic steroid or steroid eye drop use within 2 weeks prior to initiation of experimental therapy. Limited doses of systemic steroids to prevent intravenous (IV) contrast, allergic reaction or anaphylaxis (in patients who have known contrast allergies) are allowed.
6. Hematological eligibility parameters (within one month of starting therapy):

   * Granulocyte count greater than or equal to 1,500/mm(3)
   * Platelet count greater than or equal to 50,000/mm(3)
   * Hemoglobin (Hgb) greater than or equal to 8 g/dL
7. Biochemical eligibility parameters (within one month of starting therapy):

   1. Hepatic function: Bilirubin \< 1.5 mg/dl (OR in patients with Gilbert's syndrome, a total bilirubin less than or equal to 3.0 mg/dL), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 times upper limit of normal.-. Creatinine less than or equal to 1.5 X ULN
   2. Creatinine less than or equal to 1.5 X ULN
   3. Patients must be test negative for human immunodeficiency virus (HIV), Hepatitis B and C.
8. Patients must not have other active invasive malignancies within the past 2 years (with the exception of non-melanoma skin cancers) or life threatening illnesses.
9. Patients must be willing to travel to the study site for follow-up visits.
10. Patients must be greater or equal to18 years of age.
11. All patients who have received prior vaccination with vaccinia virus (for smallpox immunization) must not have a history of allergy to the vaccine.
12. Patients must understand and sign informed consent that explains the neoplastic nature of their disease, the procedures to be followed, the experimental nature of the treatment, alternative treatments, potential risks and toxicities, and the voluntary nature of participation.
13. The effects of the study agents used in this protocol on the developing human fetus are unknown. For this reason men must agree to use adequate contraception (abstinence,vasectomy, or female partner use of intrauterine device (IUD), hormonal \[birth control pills, injections, or implants\], tubal ligation) prior to study entry and for up to one month after the last vaccination.

EXCLUSION CRITERIA

1. Prior splenectomy.
2. The recombinant vaccinia vaccine should not be administered if the following apply to either recipients or, for at least 3 weeks after vaccination, their close household contacts (Close household contacts are those who share housing or have close physical contact):

   * Persons with active or a history of eczema or other eczematoid skin disorders
   * Those with other acute, chronic or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne or other open rashes or wounds) until condition resolves
   * Pregnant or nursing women; children under 3 years of age
   * Patients should have no evidence, as listed below, of being immunocompromised:
   * HIV positivity due to the potential for decreased tolerance and risk for severe side effects.
   * Hepatitis B or C positivity.
   * Concurrent use of topical steroids (including steroid eye drops) or systemic steroids. This is to avoid immunosuppression which may lead to potential complications with vaccinia (priming vaccination). Nasal or inhaled steroid use is permitted.
3. Patients with known allergy to eggs.
4. Other serious intercurrent illness.
5. Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment) or New York Heart Association class II-IV congestive heart failure.
6. Patients with significant autoimmune disease that is active or potentially life threatening if activated.
7. Patients with clinically significant cardiomyopathy requiring treatment.