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Phase I Clinical Trial of Recombinant Prostate Specific Membrane Antigen (rPSMA)-Loaded Mature Autologous Dendritic Cells (CapPVax) for the Treatment of Metastatic Horomone Refractory Prostate Cancer

Phase 1
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Phase I Clinical Trial of Recombinant Prostate Specific Membrane Antigen (rPSMA)-Loaded Mature Autologous Dendritic Cells (CapPVax) for the Treatment of Metastatic Horomone Refractory Prostate Cancer

OBJECTIVES: I. Assess the safety of recombinant prostate-specific membrane antigen
(rPSMA)-pulsed autologous dendritic cells (CaPVax) in patients with metastatic
hormone-refractory prostate cancer. II. Determine the potential clinical response in
patients treated with this regimen. III. Determine the effect of this treatment regimen on
pain, physical function, and quality of life of these patients.

OUTLINE: This is a dose-escalation, multicenter study. Patients undergo a delayed
hypersensitivity skin test with 3 common recall antigens. Autologous dendritic cells (DC)
are pulsed with recombinant prostate-specific membrane antigen (rPSMA). Patients receive
rPSMA-pulsed autologous DC (CaPVax) intradermally. Treatment repeats every 4 weeks for a
total of 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts
of 3-6 patients receive escalating doses of CaPVax 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. Quality of life questionnaires are completed five times
over the course of the study. Patients are followed at 3 months.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic hormone-refractory prostate
cancer Castrate serum testosterone less than 30 ng/dL after antiandrogen withdrawal
Progressing disease 50% increase in PSA level from the nadir PSA level confirmed twice and
measured at least 2 weeks apart OR New bone pain or new lesion on bone scan OR Progression
of soft tissue disease by CT or MRI Limited bone disease No more than 3 metastatic sites
on bone scan and minimal symptoms No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-1 Life expectancy:
At least 1 year Hematopoietic: Hemoglobin greater than 12.5 g/dL Absolute lymphocyte count
greater than 500/mm3 Absolute neutrophil count greater than 1,000/mm3 Platelet count
greater than 150,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT/SGPT less than 2
times upper limit of normal Hepatitis C negative Hepatitis B surface antigen and hepatitis
B core antigen negative No uncontrolled liver disease Renal: Creatinine less than 2.5
mg/dL Creatinine clearance greater than 50 mL/min No uncontrolled renal disease
Cardiovascular: No uncontrolled heart disease Immunologic: No history of severe asthma,
anaphylaxis, or other serious adverse reaction to vaccines or any of the antigens included
in skin test No immunodeficiency or autoimmune disease such as rheumatoid arthritis,
systemic lupus erythematosus, scleroderma, polymyositis dermatomyositis, juvenile-onset
insulin-dependent diabetes, or vasculitis Negative PPD skin test No prior BCG vaccination
or tuberculosis exposure HIV negative Other: No impending untreated spinal cord
compression or urinary outlet obstruction No other serious concurrent illness No other
prior malignancy in past 2 years except curatively treated basal cell or squamous cell
carcinoma of the skin

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for metastatic disease Endocrine therapy: See Disease Characteristics
Hormonal therapy (except antiandrogens like LHRH) must be continued Radiotherapy: No prior
radiotherapy for metastatic disease including strontium chloride Sr 89 Surgery: No prior
splenectomy Other: No prior ketoconazole At least 4 weeks since prior immunosuppressives
(e.g., prednisone or hydrocortisone) No prior investigational agents No concurrent
medication that may affect immune function except nonprescription strength doses of
nonsteroidal anti-inflammatory drugs, acetaminophen, or aspirin; low doses of
antihistamine; normal doses of vitamins; or H2 blockers No more than 2 short courses (no
more than 10 days per course) of antibiotics for treatment of minor infection in a 45 day

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Arie Belldegrun, MD, FACS

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

December 2000

Completion Date:

Related Keywords:

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



University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781