Vaccine Therapy for Stage III-IV Ovarian Cancer (7396)
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
|Closed||Ovarian Cancer||Phase I||
This phase I trial is studying the side effects, good or bad, of vaccine therapy (IGFBP-2) in treating patients with stage III-IV ovarian cancer. Vaccines made from DNA may help the body build an effective immune response to kill tumor cells.
Eligibility Criteria (must meet the following to participate in this study)
- Patients with advanced stage ovarian cancer, stages III or IV, who have been treated to complete remission with standard therapies including primary debulking surgery
- Cancer antigen 125 (CA-125) level within normal limits for the testing laboratory must be documented 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/mm^3
- Hemoglobin (Hgb) >= 10 mg/dl
- Hematocrit (Hct) >= 28%
- 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
- Patients must be at least 18 years of age.
Exclusions (conditions that would prevent participation in this study)
- Patients with any of the following cardiac conditions: symptomatic restrictive cardiomyopathy; unstable angina within 4 months prior to enrollment; New York Heart Association functional class III-IV heart failure on active treatment; symptomatic pericardial effusion
- Uncontrolled diabetes
- Patients with any contraindication to receiving sargramostim (rhuGM-CSF) based products
- Ovarian cancer of a low malignant potential phenotype or clear cell histology
- 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
- All subjects able to bear children
Last UpdatedSeptember 10, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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