Phase 1 Study of Immunization With NY-ESO-1 Protein Combined With CpG 7909 in Patients With High-Risk Stage D1 or Advanced Prostate Cancer
18 Years
N/A
Both
Prostate Cancer
Trial Information
Phase 1 Study of Immunization With NY-ESO-1 Protein Combined With CpG 7909 in Patients With High-Risk Stage D1 or Advanced Prostate Cancer
This is an open-label, fixed-dose study of immunization with NY-ESO-1 protein combined with
CpG 7909 as adjuvant in patients with histopathologically confirmed metastatic cancer of the
prostate, who have progressive disease under hormonal and/or chemotherapeutic treatment
(duration of treatment > 3 months).
Eligible patients will receive vaccinations consisting of 100µg NY-ESO-1 protein combined
with 2.5 mg CpG 7909 administered intradermally every 3 weeks for 4 doses. Twelve (12)
patients will be enrolled into this study.
Blood samples will be obtained at baseline, prior to the second, third and fourth injection
and three weeks after the fourth injection for clinical hematology, biochemistry and immune
response assessments. Blood samples for antinuclear antibody (ANA) and anti-dsDNA will be
collected at baseline and end of each study cycle.
A tumor sample, resected prior to immunization, will be tested to determine NY-ESO-1 and/or
LAGE-1 expression.
DTH testing will be performed with NY-ESO-1b in HLA-A2+ patients and with NY-ESO-1 DP4 in
HLA-DP4+ patients at baseline and at the 3-week visit following the second and fourth
vaccinations.
NY-ESO-1 and/or LAGE-1 specific antibodies will be assessed in all patients by Western Blot
and ELISA. NY-ESO-1 specific CD4+ and CD8+ T cells will be assessed by ELISPOT analysis in
all patients.
Disease status will be assessed at baseline and 3 weeks after the fourth vaccination in
patients with measurable disease.
Patients who demonstrate stable disease, minor response, partial response, or complete
response on week 13 may continue to receive vaccinations until disease progression. In
patients with mixed response, single progressive lesions may be resected and vaccination may
be continued.
Resected metastases should be typed for NY-ESO- and/or LAGE-1 expression.
Inclusion Criteria:
1. Patients must have high-risk stage D1 or metastatic prostate cancer (D2), confirmed
by review of histology.
2. Patients must have fully recovered from surgery.
3. Patients must show stable or progressive disease as assessed by X-ray, ultrasound,
and/or CT scans under hormonal and/or chemotherapeutic treatment, that had been
administered for at least three months.
4. Any pretreatment with chemo- or radiotherapy must have been discontinued for at least
four weeks prior to first dose of study agent. Hormone therapy is allowed before and
throughout the study.
5. Patients must have an expected survival of at least three months.
6. Patients must have a Karnofsky performance status of 70% or more.
7. Within the last 2 weeks prior to study day 1, vital laboratory parameters should be
within normal range, except for the following laboratory parameters, which should be
within the ranges specified:
- Leukocytes >3.000/ul
- Lymphocytes >700/ul
- Platelets >100.000/ul
- Serum creatinine <2.5 mg/dl
- ALT, AST, and total bilirubin all < 2.5 x ULN
8. Age ≥ 18 years
9. Able to give valid written informed consent.
Exclusion Criteria:
1. Clinically significant heart disease (NYHA Class III or IV).
2. Other serious illnesses, eg, active infections requiring antibiotics, bleeding
disorders.
3. Concomitant systemic treatment with corticosteroids. Topical or inhalational steroids
are permitted.
4. Metastatic disease to the central nervous system.
5. Mental impairment, in the opinion of the investigator, that may compromise the
ability to give informed consent and comply with the requirements of the study.
6. Lack of availability for immunological and clinical follow-up assessments.
7. Participation in chemotherapy, radiation therapy, or any other clinical trial
involving another investigational agent within 4 weeks prior to first dosing.
8. Being a recipient of an organ or bone marrow allograft. Having an autoimmune disease
other than vitiligo, such as, but not limited to, inflammatory bowel disease or
multiple sclerosis.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
to assess the safety of intradermal immunization with NY-ESO-1 protein combined with CpG 7909 in patients with high-risk stage D1 or advanced prostate cancer
Principal Investigator
Alexander Knuth, Prof. Dr. med.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Clinic of Oncology, University Hospital Zürich, Switzerland
Authority:
Switzerland: Swissmedic
Study ID:
LUD2003-024
NCT ID:
NCT00292045
Start Date:
December 2004
Completion Date:
January 2006
Related Keywords:
- Prostate Cancer
- NY-ESO-1 protein, immunization, advanced prostate cancer
- Prostatic Neoplasms
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