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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-06

Study Completion Date

2020-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stage III Ovarian Epithelial Cancer Stage III Ovarian Germ Cell Tumor Stage IV Ovarian Epithelial Cancer Stage IV Ovarian Germ Cell Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine)

Patients receive pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine ID monthly for 3 months.

Group Type EXPERIMENTAL

pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine

Intervention Type BIOLOGICAL

Given ID

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Interventions

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pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine

Given ID

Intervention Type BIOLOGICAL

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No