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GVAX in Advanced Prostate Cancer Patients Made Lymphopenic

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ClinicalTrials.gov Identifier: NCT00122005
Recruitment Status : Unknown
Verified February 2009 by Providence Health & Services.
Recruitment status was:  Active, not recruiting
First Posted : July 21, 2005
Last Update Posted : February 24, 2009
Providence Cancer Center, Earle A. Chiles Research Institute
Cell Genesys
Information provided by:
Providence Health & Services

Brief Summary:

Androgen (a male sex hormone) deprivation is the standard therapy for metastatic prostate cancer and results in regression or control of disease in 80-85% of patients. This hormone therapy results in a progression-free survival of 12-18 months and overall survival of 24-30 months. However, all patients ultimately develop hormone-refractory prostate cancer (HRPC). Management of HRPC patients is a significant challenge for both patient and physician. Neither past nor current chemotherapy regimens have shown curative potential in patients with HRPC. Thus new treatment strategies are a high priority.

A major focus of new treatment strategies is to enlist the aid of the immune system, particularly the development of prostate cancer vaccines. There has been a number of studies using dendritic cell based vaccines and the treatment has been well tolerated. Specific T-cell immune responses have been observed and occasional evidence for tumor regression. A reduction in serum prostate-specific antigen (PSA) has been observed as well. Lengthening the time-to-progression and delays in the onset of bone pain have been observed in subsets of patients with HRPC.

The initial preclinical observations suggesting that a granulocyte-macrophage colony-stimulating factor (GM-CSF) gene transduced allogeneic (GVAX) prostate cancer vaccine may be efficacious in poorly immunogenic cancers were reported.

The objective of this study is to evaluate the safety and immunologic effects of vaccinations with Allogeneic Prostate GVAX® (CG1940 & CG8711) in patients made lymphopenic by treatment with chemotherapy and infused with autologous peripheral blood mononuclear cells (PBMC). Clinical observations and laboratory measurements will be monitored to evaluate safety, toxicity and immune responses. Additionally, the effects of treatment on serum PSA levels and tumor response will be evaluated.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: GM-CSF gene transduced allogeneic vaccine GVAX Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Human GM-CSF Gene-Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (GVAX®) in Advanced Prostate Cancer Patients Made Lymphopenic and Infused With Autologous Peripheral Blood Mononuclear Cells
Study Start Date : July 2005
Estimated Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To evaluate the safety of combined CG1940 & CG8711, chemotherapy with cyclophosphamide +/- fludarabine and hematopoietic reconstitution in patients with advanced hormone-refractory prostate cancer (HRPC)
  2. To explore the effects of different chemotherapy regimens on the immune response of CG1940 & CG8711 vaccinated and reconstituted lymphopenic patients with HRPC
  3. To compare the frequency of tumor vaccine-specific, PSMA-specific T cells, and the titer of vaccine-specific antibodies in Cohorts A-C, compare in Cohorts A-C
  4. To evaluate in vitro sensitization (IVS) methods for their capacity to expand tumor vaccine-specific CD4+ and CD8+ T cells from the peripheral blood
  5. To determine whether the degree of lymphopenia inversely correlates with the expansion of tumor-specific CD4 and CD8 T cells
  6. To evaluate the effects of these procedures on serum PSA levels and tumor response

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

Inclusion Criteria:

  • Histologically diagnosed adenocarcinoma of the prostate
  • Progressive disease
  • ECOG performance status of 0 or 1
  • Adequate bone marrow, renal and hepatic function
  • Castrate levels of testosterone
  • May have had local radiotherapy as part of their initial treatment or 28 days after palliative radiotherapy or one chemotherapy treatment for metastatic disease

Exclusion Criteria:

  • Transitional cell, small cell or squamous cell prostate cancer
  • Systemic steroid therapy within 10-days of enrollment
  • Documented history of active autoimmune disease such as lupus, sarcoidosis, rheumatoid arthritis, glomerulonephritis or vasculitis
  • Clinically significant active infections
  • History of other malignancies over past 5-years (except non-melanoma skin cancer or controlled superficial bladder cancer)
  • Uncontrolled medical problems (i.e. neurological, cardiovascular) considered high risk for investigational new drug treatment
  • Prior treatment with an investigational drug within 30-days of study entry
  • Seropositive for HIV, hepatitis B surface antigen or hepatitis C

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 ClinicalTrials.gov identifier (NCT number): NCT00122005

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United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Sponsors and Collaborators
Providence Health & Services
Providence Cancer Center, Earle A. Chiles Research Institute
Cell Genesys
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Principal Investigator: Bernard Fox, PhD Providence Health & Services
Additional Information:
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ClinicalTrials.gov Identifier: NCT00122005    
Other Study ID Numbers: PPMC-EACRI-IRB-02-119
DOD Grant #DAMD17-03-1-0097
First Posted: July 21, 2005    Key Record Dates
Last Update Posted: February 24, 2009
Last Verified: February 2009
Keywords provided by Providence Health & Services:
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases