Status:
WITHDRAWN
A Vaccine Study for High Risk Cancers
Lead Sponsor:
Penn State University
Conditions:
Neuroblastoma
Rhabdomyosarcoma
Eligibility:
All Genders
1-70 years
Phase:
PHASE1
Brief Summary
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 hypothesi...
Detailed Description
MAGE -A1, MAGE- A3, and NY-ESO-1 are antigens that can be found with significant frequency on neuroblastoma, rhabdomyosarcoma, and osteogenic sarcoma, three relatively common solid tumors that in some...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00944580
Start Date
June 1 2009
End Date
August 1 2010
Last Update
November 24 2017
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