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GVAX in Advanced Prostate Cancer Patients Made Lymphopenic

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Providence Health & Services.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Providence Cancer Center, Earle A. Chiles Research Institute
Cell Genesys
Information provided by:
Providence Health & Services
ClinicalTrials.gov Identifier:
NCT00122005
First received: July 18, 2005
Last updated: February 23, 2009
Last verified: February 2009
  Purpose

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 Intervention Phase
Prostate Cancer
Biological: GM-CSF gene transduced allogeneic vaccine GVAX
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Providence Health & Services:

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

Estimated Enrollment: 18
Study Start Date: July 2005
Estimated Study Completion Date: July 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122005

Locations
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
Investigators
Principal Investigator: Bernard Fox, PhD Providence Health & Services
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00122005     History of Changes
Other Study ID Numbers: PPMC-EACRI-IRB-02-119, DOD Grant #DAMD17-03-1-0097
Study First Received: July 18, 2005
Last Updated: February 23, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Providence Health & Services:
Metastatic
Prostate
Advanced
Cancer
GVAX
Vaccine

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

ClinicalTrials.gov processed this record on November 27, 2014