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A Safety and Feasibility Study of Active Immunotherapy in Patients With Metastatic Prostate Carcinoma Using Autologous Dendritic Cells Pulsed With RNA Encoding Prostate Specific Antigen, PSA


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

A Safety and Feasibility Study of Active Immunotherapy in Patients With Metastatic Prostate Carcinoma Using Autologous Dendritic Cells Pulsed With RNA Encoding Prostate Specific Antigen, PSA


OBJECTIVES: I. Determine the safety and feasibility of prostate specific antigen (PSA) RNA
pulsed autologous dendritic cells in patients with metastatic prostate cancer. II. Evaluate
the presence and magnitude of cellular immune responses against PSA as a surrogate target
for immune activation in this patient population. III. Assess the presence, frequency, and
activation status of peripheral cytotoxic T lymphocytes prior to and following immunotherapy
with this regimen in these patients. IV. Evaluate humoral immune responses as evidenced on
circulating peripheral PSA specific antibodies in this patient population. V. Evaluate
delayed type hypersensitivity reactions to irradiated PSA RNA transfected dendritic cells
and other standard recall antigens prior to and following immunotherapy in these patients.
VI. Evaluate eventual clinical responses as evidenced on clinical and biochemical (PSA)
response criteria.

OUTLINE: This is a dose escalation study. Patients receive prostate specific antigen (PSA)
RNA pulsed autologous dendritic cells IV over 2 minutes followed by PSA RNA dendritic cells
intradermally on weeks 0, 2, and 4 for a total of 3 treatments. Cohorts of 3-6 patients
receive escalating doses of PSA RNA pulsed autologous dendritic cells until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 6 patients experience dose limiting toxicity. Patients are followed weekly for 3 months,
then every 3 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study within 24 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the
prostate with lymphatic, bone, visceral or soft tissue metastases (stage IV) No prostatic
transitional cell or small cell carcinoma PSA greater than 4.0 ng/dL Measurable or
evaluable disease by PSA OR Bidimensional disease on physical exam or radiologic imaging
studies Testosterone less than 50 mg/L if prior hormonal therapy with gonadal ablation
(LHRH analogues) or estrogens No previously irradiated or new CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: Greater than 6 months Hematopoietic: WBC at least 3,000/mm3 Absolute
lymphocyte count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at
least 9.0 mg/dL Hepatic: Bilirubin less than 2.0 mg/dL No hepatic disease Renal:
Creatinine less than 2.5 mg/dL No symptomatic urinary tract infection Cardiovascular: No
New York Heart Association class III or IV heart disease Pulmonary: No acute or chronic
asthma No chronic obstructive pulmonary disease Other: No history of autoimmune disease
(e.g., inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis,
scleroderma, or multiple sclerosis) No other concurrent malignancy except nonmelanoma skin
cancer or controlled superficial bladder cancer No active acute or chronic infection HIV
negative No other medical or psychological condition that would preclude study Adequate
peripheral vein access Hepatitis B surface antigen negative Hepatitis C negative

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior biologic therapy
and recovered No other concurrent immunotherapy Chemotherapy: At least 6 weeks since prior
chemotherapy and recovered No concurrent chemotherapy Endocrine therapy: See Disease
Characteristics Greater than 4 weeks since prior flutamide At least 6 weeks since prior
bicalutamide Concurrent gonadal androgen suppression with LHRH analogues allowed unless
androgen refractory disease At least 6 weeks since prior steroids No concurrent steroids
Radiotherapy: See Disease Characteristics At least 6 weeks since prior radiotherapy to the
prostate (12 weeks since strontium 89) and recovered No concurrent radiotherapy Surgery:
Prior surgical castration allowed Other: No concurrent immunosuppressants (e.g.,
azathioprine or cyclosporine)

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Johannes Vieweg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute

Authority:

United States: Federal Government

Study ID:

0408

NCT ID:

NCT00004211

Start Date:

July 1999

Completion Date:

January 2002

Related Keywords:

  • Prostate Cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710