Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00010127
Recruitment Status : Terminated
First Posted : July 30, 2003
Last Update Posted : March 21, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Duke University

February 2, 2001
July 30, 2003
March 21, 2013
November 2000
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Complete list of historical versions of study NCT00010127 on Archive Site
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Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer
A Safety and Feasibility Study of Active Immunotherapy in Patients With Metastatic Prostate Carcinoma Using Autologous Dendritic Cells Pulsed With Antigen Encoded in Amplified Autologous Tumor RNA

RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill prostate tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer.


  • Determine the safety and feasibility of autologous dendritic cells transfected with autologous total tumor RNA in patients with metastatic prostate cancer.
  • Determine the presence, frequency, and activation status of tumor specific and prostate specific antigen (PSA) specific cellular immune responses in patients treated with this regimen.
  • Determine delayed-type hypersensitivity reactions to PSA protein and other recall antigens in patients before and after being treated with this regimen.
  • Determine clinical responses based on clinical and biochemical (PSA) response criteria in patients treated with this regimen.
  • Determine a platform for immunological treatment using dendritic-cell based tumor vaccines in these patients.

OUTLINE: This is a dose escalation study.

Tumor tissue and peripheral blood stem cells are collected from patients and cultured in vitro with sargramostim (GM-CSF) and interleukin-4 for 7 days to produce dendritic cells (DC). Patients receive autologous DC transfected with autologous prostate carcinoma RNA intradermally once weekly on weeks 0-3 for a total of 4 doses.

Cohorts of 3-6 patients receive escalating doses of DC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at weeks 6, 8, 10, and 12; every 3 months for 9 months; and then annually for 2 years.

PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study within 20 months.

Phase 1
Primary Purpose: Treatment
Prostate Cancer
Biological: therapeutic autologous dendritic cells
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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March 2003
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  • Histologically confirmed metastatic adenocarcinoma of the prostate

    • Stage D1-3
    • Regional lymph node, bone, visceral, or soft tissue metastases
    • No transitional cell or small cell carcinoma
  • Testosterone less than 50 mg/L if prior treatment with luteinizing hormone releasing hormone (LHRH) analogues or estrogens
  • Evidence of androgen refractory disease after surgical castration and discontinuation of LHRH analogue therapy
  • No previously irradiated or new CNS metastases



  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • More than 6 months


  • WBC at least 3,000/mm^3
  • Hemoglobin at least 9 g/dL
  • Platelet count at least 100,000/mm^3


  • Bilirubin less than 2.0 mg/dL
  • PT at least 11.3 seconds but no greater than 13.3 seconds
  • PTT at least 20.1 seconds but no greater than 32.9 seconds
  • No hepatic disease
  • No viral hepatitis


  • Creatinine less than 2.5 mg/dL


  • No New York Heart Association class III or IV heart disease


  • No asthma
  • No chronic obstructive pulmonary disease
  • No severe lung disease


  • No other medical illness or psychological impediment that would preclude study
  • No other concurrent malignancy except nonmelanoma skin cancer or controlled superficial bladder cancer
  • No active acute or chronic infection including symptomatic urinary tract infection
  • No autoimmune disease (e.g., inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, or multiple sclerosis)
  • HIV negative
  • Adequate peripheral vein access


Biologic therapy:

  • Prior biologic therapy allowed
  • No other concurrent immunotherapy


  • Prior chemotherapy allowed
  • No concurrent chemotherapy

Endocrine therapy:

  • See Disease Characteristics
  • At least 4 weeks since prior non-steroidal hormonal therapy if increase in PSA while receiving non-steroidal hormonal therapy
  • At least 6 weeks since prior steroids
  • Concurrent LHRH analogues for gonadal androgen suppression allowed
  • No concurrent steroid therapy
  • No concurrent corticosteroids


  • See Disease Characteristics
  • Prior palliative radiotherapy for bone metastases allowed
  • Prior prostatic radiotherapy allowed
  • At least 4 weeks since prior radiotherapy
  • At least 12 weeks since prior strontium chloride Sr 89
  • No concurrent radiotherapy


  • See Disease Characteristics


  • Recovered from prior therapy
  • No concurrent immunosuppressive agents (e.g., azathioprine or cyclosporine)
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000068447 ( Other Identifier: NCI )
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Duke University
Duke University
National Cancer Institute (NCI)
Study Chair: Johannes Vieweg, MD Duke Cancer Institute
Duke University
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP