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A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox)/TRICOM With GM-CSF in Patients With Prostate-Specific Antigen (PSA) Progression After Local Therapy for Prostate Cancer

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox)/TRICOM With GM-CSF in Patients With Prostate-Specific Antigen (PSA) Progression After Local Therapy for Prostate Cancer



- To evaluate the effect of PROSTVAC-V/TRICOM (Vaccinia) on cycle 1 followed by
PROSTVAC-F/TRICOM (Fowlpox) and GM-CSF on biochemical PSA progression at 6 months.


- To determine the change in PSA velocity pre-treatment to post-treatment.

- To evaluate the percentage of patients experiencing a >50% decline in serum PSA
repeated at 4 weeks.

- To evaluate tolerability and any toxicity related to treatment with PSA vaccine and

- To determine the effect of GM-CSF on PSA immediately after treatment (day 4) compared
to a delayed effect (day 15).

OUTLINE: This is a multicenter study.

Patients receive vaccinia-PSA-TRICOM vaccine subcutaneously (SC) on day 1 and sargramostim
(GM-CSF) SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive
fowlpox-PSA-TRICOM vaccine SC on day 1 and GM-CSF SC on days 1-4. Treatment with
fowlpox-PSA-TRICOM vaccine and GM-CSF repeats every 4 weeks for 2 courses (weeks 5 and 9).
Beginning in week 13, patients receive fowlpox-PSA-TRICOM vaccine and GM-CSF as above every
12 weeks in the absence of clinical or biochemical disease progression or unacceptable

Patients with biochemical or clinical disease progression may start androgen ablation
therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4
weeks in addition to fowlpox-PSA-TRICOM vaccine and GM-CSF. Treatment continues in the
absence of further clinical or biochemical disease progression.

After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 3 years, and then annually for 10 years.

ACTUAL ACCRUAL: A total of 50 patients were accrued for this study.

Inclusion Criteria:

- Histologically confirmed prostate cancer and tumors limited to the prostate

- Seminal vesical involvement allowed provided all visible disease has been
surgically removed

- Prior treatment with definitive surgery or radiation therapy or both

- At least 1 year since prior neoadjuvant/adjuvant chemotherapy or hormonal therapy

- More than 1 year since prior testosterone level-modulating therapy, such as LHRH
agonists/antagonists and antiandrogens

- Hormone-sensitive disease as evident by a serum total testosterone level > 150 ng/dL
within 4 weeks prior to registration

- Evidence of PSA progression after completion of definitive surgery and/or
radiotherapy, as demonstrated by all of the following:

- Three consecutively rising PSA values within the past 6 months, each obtained ≥
4 weeks apart

- Most recent PSA value > 0.4 ng/mL (after prostatectomy) OR > 1.5 ng/mL (after

- PSA doubling time < 12 months

- ECOG PS of 0-1

- Age of 18 and over

- WBC ≥ 3,000/mm^3

- Granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Urine protein < 1,000 mg by 24-hour urine collection AND no evidence of chronic renal
disease (Creatinine normal or Creatinine clearance ≥ 60 mL/min)

- AST and ALT ≤ 2.5 times upper limit of normal

- Bilirubin normal

- Alkaline phosphatase normal

- Hepatitis B and hepatitis C negative

- PT/INR normal

- Human immunodeficiency virus sero-negative

- Recovered from prior therapy

- Patients must use a safe and effective method of contraception to prevent virus

- Patients must agree to avoid fathering a child and use a latex barrier with adequate
contraception prior to study entry and for at least 4 months following the last
vaccine injection

- All sites of disease must be evaluated within 4 weeks prior to registration

- Recovered from any other illness

- Must be able to avoid close contact (i.e., shares the same house or has close
physical contact) with any of the following individuals for ≥ 3 weeks after treatment
with the study vaccinia vaccine:

- Individuals with a history of or active eczema, atopic dermatitis, Darier's

- Individuals with other acute, chronic, or exfoliative skin condition, including
any of the following:

- Burns

- Impetigo

- Varicella zoster

- Severe acne

- Contact dermatitis

- Psoriasis

- Herpes

- Other open rashes or wounds

- Pregnant or nursing women

- Children ≤ 3 years of age

- Immunodeficient or immunosuppressed individuals either by disease or therapy,
including HIV-positive individuals

- Concurrent thyroid hormone-replacement therapy allowed

Exclusion Criteria:

- Lymph node involvement

- Metastatic disease by physical exam, CT scan, MRI, or bone scan within 4 weeks of

- Prior vaccine therapy or immunotherapy for prostate cancer

- Administration of any of the following agents during the period in which the PSA
levels are collected:

- 5α-reductase inhibitors

- Ketoconazole

- Megestrol acetate

- Systemic steroids

- Herbal products

- Proteinuria or abnormal sediment by urine analysis

- Active autoimmune disease, including any of the following:

- Addison's disease

- Hashimoto's thyroiditis

- Systemic lupus erythematosus

- Sjögren's syndrome

- Scleroderma

- Myasthenia gravis

- Goodpasture's syndrome

- Active Graves' disease

- History of autoimmune disease that has required systemic immunosuppressive therapy or
has impaired central nervous system (CNS), heart, lung, kidney, skin, or
gastrointestinal tract function

- Concurrent systemic steroids

- Local (e.g., topical, nasal, inhaled) steroids allowed

- No steroid eye drops for ≥ 2 weeks before and ≥ 4 weeks after vaccinia

- Receiving other investigational agents or concurrent anticancer therapy

- Uncontrolled intercurrent illness

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness or social situation that would preclude study compliance

- Clinically significant cardiomyopathy

- Significant allergy or hypersensitivity to eggs

- History of allergy or untoward reaction to prior vaccination with vaccinia virus or
to any component of the study vaccinia vaccine regimen

- History of or active eczema

- Ongoing, active infection

- Atopic dermatitis

- Darier's disease

- Other acute, chronic, or exfoliative skin condition, including any of the following:

- Burns

- Impetigo

- Varicella zoster

- Severe acne

- Contact dermatitis

- Psoriasis

- Herpes

- Other open rashes or wounds

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of Patients Free of PSA Progression at 6 Months (Prior to the Start of Androgen Ablation)

Outcome Description:

For patients who achieved a > 50% decline in PSA, an increase in PSA value by 50% over the nadir, confirmed by a second PSA two weeks later is considered progressive disease. The PSA rise must be at least 5 ng/mL or back to pretreatment baseline, whichever is greater. Changes in PSA below 5 ng/mL will not be considered assessable for progression. For patients whose PSA has not decreased by 50%, an increase in PSA value > 50% of baseline (on trial) or nadir PSA, whichever is lower, confirmed by a repeat PSA two weeks later is considered progressive disease. The PSA must have risen by at least 5 ng/mL.

Outcome Time Frame:

Assessed at 6 months

Safety Issue:


Principal Investigator

Robert S. DiPaola, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Institute of New Jersey


United States: Food and Drug Administration

Study ID:




Start Date:

February 2006

Completion Date:

January 2023

Related Keywords:

  • Prostate Cancer
  • Recurrent prostate cancer
  • Vaccinia
  • Fowlpox
  • Prostatic Neoplasms



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