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Complete title: A Phase I Trial of the Safety and Immunogenicity of a DNA Plasmid Based Vaccine Encoding the Amino Acids 1-163 of Insulin-Like Growth Factor Binding Protein-2 (IGFBP-2) in Patients with Advanced Ovarian Cancer
|Research Study Number||7396|
|Principal Investigator||Nora Disis, MD|
Research Study Description
-To determine the safety of an IGFBP-2 Th polyepitope plasmid based vaccine in patients with advanced stage or recurrent ovarian cancer.
-To determine the immunogenicity of IGFBP-2 Th polyepitope plasmid based vaccine in patients with advanced stage or recurrent ovarian cancer.
Eligibility Criteria (must meet the following to participate in this study)
- Patients with advanced stage (III/IV) or recurrent ovarian cancer, who have been treated to complete remission with standard therapies including primary debulking surgery.
- A CA-125 level within normal limits for the testing laboratory must be documented within 90 days prior to enrollment when the assessment of CA-125 is applicable
- Patients must be at least 28 days post cytotoxic chemotherapy, and/or monoclonal antibody therapy, prior to enrollment
- Patients must be at least 28 days post systemic steroids prior to enrollment
- Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status Score of =< 2
- Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment
- Estimated life expectancy of more than 6 months
- White Blood Cell (WBC) >= 3000/mm3
- Hemoglobin (Hgb) >= 10 mg/dl
- Serum creatinine =< 2.0 mg/dl or creatinine clearance > 60 ml/min
- Total bilirubin =< 2.5 mg/dl
- Aspartate aminotransferase (AST)/Serum glutamic oxaloacetic transaminase (SGOT) =< 3 times upper limit of normal (ULN)
- Blood glucose < 1.5 ULN
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Uncontrolled diabetes
- Patients with any contraindication to receiving sargramostim (rhuGM-CSF) based products
- Ovarian cancer of a low malignant potential phenotype
- Patients with any clinically significant autoimmune disease uncontrolled with treatment
- Patients who are currently receiving an anti-IGF-IR monoclonal antibody as part of their treatment regimen
- Patients who are simultaneously enrolled in any other treatment study
Other exclusion criteria may apply.
Gynecological Cancer; Ovarian Cancer; Solid Tumors; Primary Peritoneal Cancer (PPC)
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