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Trial record 5 of 30 for:    IGFBP2

Vaccine Therapy in Treating Patients With Stage III-IV or Recurrent Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01322802
Recruitment Status : Active, not recruiting
First Posted : March 25, 2011
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

Tracking Information
First Submitted Date  ICMJE March 7, 2011
First Posted Date  ICMJE March 25, 2011
Last Update Posted Date April 4, 2019
Actual Study Start Date  ICMJE March 6, 2012
Actual Primary Completion Date January 9, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2014)
Safety as assessed per Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 16 months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2011)
  • Safety as assessed using National Cancer Institute (NCI) common toxicity criteria [ Time Frame: At second and third vaccine administrations and month 4 ]
  • Immunogenicity, via cellular immune response and humoral immune response, as assessed by the generation of IGFBP-2 specific T cells and IgG antibodies [ Time Frame: At baseline and months 4, 9, and 15 ]
Change History Complete list of historical versions of study NCT01322802 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2014)
  • Immunogenicity, via cellular immune response and humoral immune response, as assessed by the generation of IGFBP-2 specific T cells and IgG antibodies [ Time Frame: Up to 16 months ]
    Cellular immune response will be defined by the magnitude of the Th1 antigen specific immune response using IFN-gamma enzyme-linked immunosorbent spot (ELISPOT). Humoral immune response will be measured by enzyme-linked immunosorbent assay (ELISA) and serum antibody avidity for IGFBP-2 using ELISA to determine an avidity index (AI) before and after vaccination. Spearman's correlation coefficient will be used to estimate the correlation between two continuous measures.
  • Epitope spreading with the generation of an IGFBP-2 Th1 immune response [ Time Frame: Up to 16 months ]
    Peripheral blood mononuclear cells (PBMC) will be assessed by ELISPOT for immunity to a panel of immunogenic ovarian cancer related proteins: topoisomerase II-alpha (a), p53, IGF-IR, FASCIN-1, and MMP-7. Epitope spreading will have been considered to occur if new immune responses are generated to any of these antigens during the course of the study. In addition, epitope spreading and T regulatory cells will be defined as present or absent, and the probability of each will be estimated as a simple proportion as above with toxicity.
  • Levels of regulatory T- cells (Tregs) over the course of immunization to detect modulation of Tregs with vaccination [ Time Frame: Up to 16 months ]
    Assessed by flow cytometry of PBMC. In addition, epitope spreading and T regulatory cells will be defined as present or absent, and the probability of each will be estimated as a simple proportion as above with toxicity.
  • Disease-free survival [ Time Frame: Up to 5 years ]
    A questionnaire will be sent to the patient's primary oncologist requesting laboratory evaluation of toxicity, CA-125, and the patient's disease free and overall survival status.
  • Overall survival [ Time Frame: Up to 5 years ]
    A questionnaire will be sent to the patient's primary oncologist requesting laboratory evaluation of toxicity, CA-125, and the patient's disease free and overall survival status
Original Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2011)
  • Epitope spreading with the generation of an IGFBP-2 Th1 immune response [ Time Frame: At baseline and months 4, 9, and 15 ]
  • Levels of regulatory T- cells (Tregs) over the course of immunization to detect modulation of Tregs with vaccination [ Time Frame: At baseline and months 4, 9, and 15Up ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vaccine Therapy in Treating Patients With Stage III-IV or Recurrent Ovarian Cancer
Official Title  ICMJE 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
Brief Summary This phase I trial is studying the side effects of vaccine therapy in treating patients with stage III-IV or recurrent ovarian cancer. Vaccines made from deoxyribonucleic acid (DNA) may help the body build an effective immune response to kill tumor cells.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stage III Ovarian Epithelial Cancer
  • Stage III Ovarian Germ Cell Tumor
  • Stage IV Ovarian Epithelial Cancer
  • Stage IV Ovarian Germ Cell Tumor
Intervention  ICMJE
  • Biological: pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine
    Given ID
  • Other: laboratory biomarker analysis
    Correlative studies
Study Arms  ICMJE Experimental: Treatment (pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine)
Patients receive pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine ID monthly for 3 months.
Interventions:
  • Biological: pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine
  • Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 23, 2011)
22
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 9, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01322802
Other Study ID Numbers  ICMJE 7396
NCI-2011-00099 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
134
7396 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Mary Disis Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
PRS Account University of Washington
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP