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SCCA Gynecologic Cancer Clinical Trials

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
Status Conditions Phase Study ID
Recruiting Ovarian Cancer Phase I 7396/134
NCT01322802
Summary

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.


Investigator
Mary L. Disis, MD
Location    
University of Washington - Tumor Vaccine Group 206-543-6620, TVGTrial@uw.edu  
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 Updated
June 01, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.