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A Pilot Trial of Pox Vector PSA Vaccine With Concurrent Docetaxel Versus Pox Vector Vaccine Followed by Docetaxel in Metastatic Androgen Independent Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

A Pilot Trial of Pox Vector PSA Vaccine With Concurrent Docetaxel Versus Pox Vector Vaccine Followed by Docetaxel in Metastatic Androgen Independent Prostate Cancer


- Compare the relative change in prostate-specific antigen (PSA)-specific T-cell
precursors (CD8) from baseline to day 85 in patients with metastatic
androgen-independent prostate cancer treated with a vaccination regimen comprising
fowlpox-PSA vaccine, recombinant rV-B7.1 vaccine, recombinant vaccinia-PSA vaccine, and
sargramostim (GM-CSF) with or without docetaxel.

- Compare the safety of these regimens in these patients.

- Compare clinical activity of these regimens in these patients.

- Determine the immunologic effects in these patients after additional
vaccine/chemotherapy courses.

- Measure CD4 T-cell responses to the vaccine in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms after
receiving priming vaccinations.

- Priming vaccinations: All patients receive recombinant vaccinia-prostate-specific
antigen (PSA) vaccine subcutaneously (SC) and recombinant rV-B7.1 vaccine SC on day 1
and sargramostim (GM-CSF) SC on days 1-4. Patients then receive fowlpox-PSA vaccine
(F-PSA) SC on day 15 and GM-CSF SC on days 15-18.

- Arm I: Patients receive docetaxel IV over 30 minutes on days 29, 36, and 43; F-PSA SC
on day 30; and GM-CSF SC on days 30-33. Treatment repeats beginning on day 56 for one
more course. Patients who do not have disease progression at day 85 receive docetaxel
weekly for 3 weeks and F-PSA on day 1 of each course. Courses repeat every 4 weeks in
the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive F-PSA SC on days 29 and 57 and GM-CSF SC on days 29-32 and
57-60. Patients who show disease progression after day 85 either radiographically or by
rising PSA stop receiving the vaccine and may receive docetaxel weekly for 3 weeks.
Chemotherapy repeats every 4 weeks in the absence of disease progression or
unacceptable toxicity.

PROJECTED ACCRUAL: A total of 28 patients (14 per treatment arm) will be accrued for this
study within 9-10 months.

Inclusion Criteria


- Diagnosis of androgen-independent metastatic adenocarcinoma of the prostate,
confirmed by 1 of the following:

- Histologically confirmed disease

- Pathologically documented disease and clinical course consistent with prostate

- Castrate levels of testosterone with progressive disease by at least 1 of the
following parameters:

- 2 consecutively rising prostate-specific antigen levels, separated by at least 1
week, with at least 1 measurement that is 50% above the nadir reached after the
last therapeutic maneuver (must be at least 5 ng/mL)

- At least 1 new metastatic deposit on technetium Tc 99 bone scintigraphy

- Progression of soft-tissue metastases by imaging or palpation, as indicated by:

- Development of new area of malignant disease

- At least 20% increase in sum of the longest dimension of target lesions

- Serum testosterone less than 50 ng/dL if no prior surgical castration

- Luteinizing hormone-releasing hormone therapy must continue

- HLA-A2 positive

- No brain metastases



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- More than 6 months


- Granulocyte count at least 1,500/mm^3

- Lymphocyte count at least 500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin less than 1.5 mg/dL

- AST and ALT less than 2.5 times upper limit of normal (ULN)

- Alkaline phosphatase no greater than 2.5 times ULN OR

- Hepatic alkaline phosphatase fraction less than 2.5 times ULN


- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 40 mL/min

- Proteinuria grade 0-1 OR

- Protein less than 1,000 mg by 24-hour urine collection

- No hematuria

- No abnormal sediment unless non-renal


- No unstable or newly diagnosed angina pectoris

- No myocardial infarction within the past 6 months

- No New York Heart Association class II-IV congestive heart failure

- No concurrent clinically significant cardiomyopathy requiring treatment


- No prior allergy or untoward reaction to vaccinia virus vaccination

- No altered immune function, including:

- Eczema

- Atopic dermatitis


- Autoimmune disease

- Autoimmune neutropenia

- Thrombocytopenia

- Hemolytic anemia

- Systemic lupus erythematosus

- Sjogren's syndrome

- Scleroderma

- Myasthenia gravis

- Goodpasture syndrome

- Addison's disease

- Hashimoto's thyroiditis

- Active Graves' disease

- Multiple sclerosis

- No extensive psoriasis, severe acneiform rash, impetigo, varicella zoster, burns, or
other traumatic or pruritic skin condition

- No known allergy to eggs


- No other malignancy within the past 2 years except nonmelanoma skin cancer or
carcinoma in situ of the bladder

- No other life-threatening or serious illness

- No unhealed surgical scars

- No household or close physical contact with persons with any of the following
conditions during or for 2 weeks after study treatment:

- Eczema or eczematoid skin disorders

- Acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns,
impetigo, varicella zoster, severe acne, or other open rashes or wounds)

- Pregnant or nursing women

- Children under 5 years of age

- Immunodeficient or immunosuppressed (including HIV positive) individuals

- No history of seizures or encephalitis


Biologic therapy

- Not specified


- No prior taxanes for metastatic prostate cancer

Endocrine therapy

- See Disease Characteristics

- At least 4 weeks since prior flutamide

- At least 6 weeks since prior bicalutamide or nilutamide

- No concurrent steroids except topical steroids, inhaled steroids for mild or moderate
asthma, or decadron as premedication for chemotherapy


- Not specified


- See Disease Characteristics

- No prior splenectomy


- Recovered from prior therapy

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Philip M. Arlen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

August 2002

Completion Date:

October 2007

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms



Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda, Maryland  20892-1182