Neuroblastoma Clinical Trial
Official title:
A Phase 1 Study to Determine the Immunologic Effects of a MAGE- A1, MAGE- A3, NY-ESO-1 Vaccine in Patients With High Risk Neuroblastoma, Osteogenic Sarcoma, and Rhabdomyosarcoma
Verified date | November 2017 |
Source | Penn State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the safety and immunological effects of a vaccine for people diagnosed with high risk neuroblastoma, osteogenic sarcoma, and rhabdomyosarcoma. It is hypothesized that this vaccine could reduce the incidence of relapse.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 70 Years |
Eligibility |
Inclusion Criteria for Screening Phase: Patient 1 to 70 years of age with neuroblastoma, rhabdomyosarcoma, or osteogenic sarcoma, who have one or more of the following high risk features: - Neuroblastoma: - Stage IV disease - Stage III disease with n-myc amplification - Osteogenic sarcoma: - Presence of metastases - Elevated alkaline phosphatase or LDH at diagnosis - Primary tumor affecting the axial skeleton - Poor histopathological response after completion of pre-surgical chemotherapy (=10% viable tumor) - Rhabdomyosarcoma: - Stage IV disease - Alveolar histology - Positive tumor margins, with lymph node positivity Inclusion Criteria for Vaccine Phase: - Patient meets all screening criteria and tumor is positive for NY-ESO-1, MAGE- A1, or MAGE-A3 by immunohistochemistry or RT-PCR. - Patients who are between 3 months and 2 years following the completion of therapy, and have achieved at least a very good partial response to primary therapy. - No chemotherapy is planned for one month following the last vaccination. - Bilirubin <2 mg/dL, and SGOT/SGPT <2.5 x normal - Creatinine clearance > 50ml/min as estimated by patient's serum creatinine, weight, and age - Room air pulse oximetry >94% - Patient is not pregnant - Male and female sexually active patients of reproductive who wish to participate must agree to use acceptable contraception - Patient is not moribund and has a projected life expectancy >6 months - Lansky performance scale > 70, ECOG < 2 (Appendix I) - Potential subjects will be tested for HIV 1 and 2 antibodies, HTLV 1/2 antibodies, and for HIV 1, hepatitis C and hepatitis B virus by NAT testing. - -Subjects testing positive for any of these pathogens will be ineligible for vaccine. - White blood cells = 2.5 K/µL, Hemoglobin = 8 g/dL, Hematocrit > 25%, and Platelets = 70 K/µL - Patient does not have central nervous system involvement. - Patient does not a have a history of autoimmune disease, specifically inflammatory bowel disease, systemic lupus erythematosis, or rheumatoid arthritis - Patient is not receiving concurrent systemic steroid therapy - Patient does not have a known systemic hypersensitivity to imiquimod or any vaccine component |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Penn State University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary objective is to determine if there is an amplification or new development of NY-ESO-1, MAGE-A1, or MAGE-A3 specific CD4+ or CD8+ T cells post-vaccination. | 2 years | ||
Secondary | The investigators will determine the safety of vaccine and imiquimod administration in these patients. | 2 years |
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