GVAX in Advanced Prostate Cancer Patients Made Lymphopenic

NCT00122005 | Unknown Phase 1

• 2 other identifiers: PPMC-EACRI-IRB-02-119DOD Grant #DAMD17-03-1-0097
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Metastatic; Prostate; Advanced; Cancer; GVAX; Vaccine

Outcome Measures

Primary Outcomes (6)

• 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

Interventions

GM-CSF gene transduced allogeneic vaccine GVAX BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Providence Health & Services: lead
• Providence Cancer Center, Earle A. Chiles Research Institute: collaborator
• Cell Genesys: collaborator

Study Sites (1)

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bernard Fox, PhD

  Providence Health & Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 18, 2005
• First Posted: July 21, 2005
• Study Start: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: February 24, 2009

Record last verified: 2009-02

Locations

US (1)