Safety and Effectiveness of a Vaccine for Prostate Cancer That Uses Each Patients' Own Immune Cells.

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Prostate Cancer

In brief

The purpose of this study is to assess the safety and activity of a type of vaccine as immune therapy for prostate cancer. This vaccine will be made for each participant's own immune cells (called dendritic cells) obtained by blood donation. Dendritic cells are immune cells, whose role is to identify foreign antigens (bacteria, viruses, or tumor cells, for example) in the body and to activate other cells of the immune system to mount an attack on that foreign antigen. Each participant will be randomized into either Arm 1 (experimental treatment only) or Arm 2 (placebo first, then the experimental treatment). Participants will be given the vaccine and three boosters as an injection. After the placebo phase, each participant in Arm 2 will crossover to the treatment phase so that all participants will eventually receive the experimental treatment.

Key facts

Study ID

NCT00289341

Run by

Rockefeller University

People needed

24

Starts

2002-03-01

Expected to finish

2008-11-01

Last updated by the study team

2013-01-18

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Disease Characteristics
• Histologically confirmed prostate carcinoma
• Progressive, disease required, i.e.: elevated PSA documented to be rising on 3 occasions, either despite castrate testosterone levels (below 50 ng/dl), or after definitive local therapy (prostatectomy or radiation).
• Prior/Concurrent Therapy
• Biologic therapy:
• Recovered from toxicity of any prior therapy
• Chemotherapy:
• At least 4 weeks since chemotherapy -Endocrine evaluation/therapy
• 3 rising PSA values at least 2 weeks apart
• At least 2 weeks since concurrent corticosteroids (other than for replacement therapy for adrenal insufficiency)
• Medical hormonal therapy to maintain castrate testosterone levels permitted
• Radiotherapy:
• At least 4 weeks since radiotherapy
• Surgery:
• Prior surgery allowed
• Patient Characteristics
• Age: 18 and over, able to give written informed consent. Individuals unable to provide informed consent must have consent provided by the legal guardian, or person designated by the subject to give consent on his behalf.
• Performance status: Karnofsky 70-100%
• Life expectancy: At least 1 year
• Hematopoietic: obtained twice, once within 45 days prior to study entry, and again within 72 hours of study entry.
• WBC greater than 3,800
• Absolute neutrophils greater than 1,500
• Absolute lymphocytes greater than 500
• Platelets greater than 120,000
• Hb at least 10 g/dl

You may not qualify if…

• Disease Characteristics -No active CNS metastases
• Prior/Concurrent Therapy
• Biologic therapy:
• No prior autologous or allogeneic tumor vaccines
• No concurrent other immunotherapy
• Chemotherapy
• -Not previously treated with more than 2 chemotherapy regimens
• No concurrent chemotherapy
• Radiotherapy --No concurrent radiotherapy
• Patient Characteristics -Cardiovascular: No NYHA class III/IV status No active angina, clinically significant cardiac arrythmia, recent (6 months) myocardial infarction
• Pulmonary:
• -No severe debilitating pulmonary disease
• Other:
• No active infection requiring antibiotics
• No active pain requiring chronic opioid analgesics.
• Not HIV, hepatitis B or hepatitis C virus positive; anti-HIV, HbsAg and Hep C antibody negative
• No history of hypersensitivity to vaccine components
• No serious uncontrolled medical illness
• No currently active second malignancy other than non-melanoma skin cancer (note: a patient is NOT considered to have currently active malignancy if they have completed therapy and are now considered by their physician to be at less than 30% risk for relapse)
• No history of total lymph node irradiation
• No history of vasculitis, including but not limited to systemic necrotizing vasculitides (polyarteritis nodosa group), hypersensitivity vasculitis, Wegener's granulomatosis.
• No history of autoimmune disease.
• No use of hydroxyurea within 45 days of study entry
• No receipt of immune modulators or suppressors within 30 days prior to study entry, including but not limited to interferons and thalidomide. No active requirement for corticosteroids; prior use is acceptable.
• No psychiatric illness or social condition that, in the opinion of the investigator, would interfere with adherence to study requirements.

Where it is running

• Rockefeller University Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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