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

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: therapeutic autologous dendritic cells Phase 1

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2000
Actual Study Completion Date : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00010127

United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
Study Chair: Johannes Vieweg, MD Duke Cancer Institute

Responsible Party: Duke University Identifier: NCT00010127     History of Changes
Other Study ID Numbers: 0759
CDR0000068447 ( Other Identifier: NCI )
First Posted: July 30, 2003    Key Record Dates
Last Update Posted: March 21, 2013
Last Verified: December 2008

Keywords provided by Duke University:
adenocarcinoma of the prostate
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases