Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Stage III-IV or Recurrent Ovarian Cancer
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
NCT01322802CI-TRIAL-00050319completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage III Ovarian Epithelial Cancer | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
| Stage III Ovarian Germ Cell Tumor | Ovarian Germ Cell Tumor | CURATED_BROADER | 0.78 |
| Stage IV Ovarian Epithelial Cancer | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Ovarian Germ Cell Tumor | Ovarian Germ Cell Tumor | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine)
- description
- Patients receive pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine ID monthly for 3 months.
- interventionNames
- Biological: pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Safety as assessed per Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- timeFrame
- Up to 16 months
- 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.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.