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
18 Years
N/A
Female
Stage III Ovarian Epithelial Cancer, Stage III Ovarian Germ Cell Tumor, Stage IV Ovarian Epithelial Cancer, Stage IV Ovarian Germ Cell Tumor
Trial Information
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
PRIMARY OBJECTIVES:
I. To determine the safety of an insulin like growth factor binding protein 2 (IGFBP-2) Th
polyepitope plasmid based vaccine in patients with advanced stage or recurrent ovarian
cancer.
SECONDARY OBJECTIVES:
I. To determine the immunogenicity of IGFBP-2 Th polyepitope plasmid based vaccine in
patients with advanced stage or recurrent ovarian cancer.
II. To determine whether intermolecular epitope spreading occurs with the generation of an
IGFBP-2 specific Th1 immune response.
III. To determine whether IGFBP-2 vaccination modulates T regulatory cells.
OUTLINE:
Patients receive pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine intradermally (ID)
monthly for 3 months.
After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months, and
then every 6 months for 5 years.
Inclusion Criteria:
- Patients with advanced stage (III/IV) or recurrent ovarian cancer 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
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety as assessed per Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Outcome Description:
Demographic and background characteristics obtained at enrollment will be listed and summarized. The type and grade of toxicities noted during the immunization regimen will be summarized. All adverse events noted by the investigator will be tabulated according to the affected body system. Descriptive statistics will be used to summarize changes from baseline in clinical laboratory parameters.
Outcome Time Frame:
Up to 12 months
Safety Issue:
Yes
Principal Investigator
Mary Disis
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Authority:
United States: Food and Drug Administration
Study ID:
7396
NCT ID:
NCT01322802
Start Date:
March 2012
Completion Date:
Related Keywords:
- Stage III Ovarian Epithelial Cancer
- Stage III Ovarian Germ Cell Tumor
- Stage IV Ovarian Epithelial Cancer
- Stage IV Ovarian Germ Cell Tumor
- Ovarian Cancer; Vaccine; Stage III; Stage IV; Remission
- Ovarian Neoplasms
- Neoplasms, Germ Cell and Embryonal
- Germinoma
- Neoplasms, Glandular and Epithelial
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
