Clinical 143

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 (OC)
Study Design
This will be a Phase I single arm, non-randomized study in patients with advanced stage ovarian cancer (III/IV) who have been treated to complete remission following primary or salvage therapy.
Study Contact
Stephanie Parker | 866.932.8588 | E-Mail
Patient Population
  1. Patients with stage III or IV ovarian cancer, who have been treated to complete remission with standard therapies including primary debulking surgery
  2. A CA-125 level within normal limits at least 90 days prior to enrollment
  3. Prior to enrollment patients must be at least 28 days post cytotoxic chemotherapy, systemic steroids, and/or monoclonal antibody therapy
  4. Patients must have recovered from major infections and/or surgical procedures
  5. Adequate laboratory values within 30 days of enrollment
  6. Patients must be at least 18 years of age
  7. Patients cannot have uncontrolled diabetes, or any uncontrolled clinically significant autoimmune disease
  8. Patients cannot be receiving an anti-IGF-IR monoclonal antibody as part of their current treatment regimen
  9. Patients cannot be currently enrolled in any other treatment study
  10. Patients with an ovarian cancer of a low malignant potential phenotype or clear cell histology are excluded
Number of Patients: This study will accrue a total of 22 patients.
Patients Visits

Seven total visits over 15 months - all in Seattle

  1. IGFBP-2 DNA vaccines: 3 vaccines given 28 days apart (+ 7 days if needed)
  2. Follow-Up Visit #1: 1 month after final vaccine
  3. Follow-Up Visit #2: Leukapheresis (blood draw if leukapheresis cannot be done) 3 months after final vaccine
  4. Follow-Up Visit #3 & #4: 6 and 12 months after your last vaccine
  5. Will request information (i.e. laboratory values disease status, ect.) from your primary physician/oncologist every 6 months for 5 years
Objectives
  1. To determine the safety and immunogenenicity of an IGFBP-2 polyepitope plasmid based vaccine in patients with advanced stage ovarian cancer
  2. To determine whether epitope spreading occurs with the generation of an IGFBP-2 specific immunity
  3. To determine whether IGFBP-2 vaccination decreases the immune suppression seen in ovarian cancer
Start Date: March 2012
Study Location: University of Washington Medical Center | 1959 NE Pacific Street | Seattle, WA 98195
Scientific Description
ClinicalTrials.gov Identifier: NCT01322802
Page last updated

03/01/2012

Clinical Trials Contact

For more information regarding our trials, please call our Patient Coordinator

Doreen Higgins
866-932-8588
Email