IGFBP-2 Vaccine and Combination Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Undergoing Surgery

• Sponsor: University of Washington (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03029611
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 11
• Location: 1
• Arm: 1
• Actual Duration (Months): 32.2
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This phase II trial studies how well pUMVC3-IGFBP2 plasmid deoxyribonucleic acid (DNA) vaccine (IGFBP-2 vaccine) and combination chemotherapy work in treating patients with stage III-IV ovarian, fallopian tube, or primary peritoneal cancer undergoing surgery. IGFBP-2 is a protein found in the blood and tumor cells of most who have been diagnosed with ovarian cancer. Too much IGFBP-2 has been associated with more invasive disease. Vaccines made from DNA may help the body build an effective immune response to kill tumor cells that express IGFBP-2. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving IGFBP-2 vaccine and combination chemotherapy may work better in treating patients with stage III-IV ovarian, fallopian tube, or primary peritoneal cancer undergoing surgery.

Condition or Disease	Intervention/Treatment	Phase
Stage III Fallopian Tube Cancer; Stage III Ovarian Cancer; Stage III Primary Peritoneal Cancer; Stage IIIA Fallopian Tube Cancer; Stage IIIA Ovarian Cancer; Stage IIIA Primary Peritoneal Cancer; Stage IIIB Fallopian Tube Cancer; Stage IIIB Ovarian Cancer; Stage IIIB Primary Peritoneal Cancer; Stage IIIC Fallopian Tube Cancer; Stage IIIC Ovarian Cancer; Stage IIIC Primary Peritoneal Cancer; Stage IV Fallopian Tube Cancer; Stage IV Ovarian Cancer; Stage IV Primary Peritoneal Cancer	Drug: Carboplatin; Procedure: Gynecological Surgical Procedure; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Biological: pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

1. Determine whether the addition of an IGFBP-2 vaccine to neoadjuvant chemotherapy increases the rate of complete pathologic response (CR).

SECONDARY OBJECTIVES:

1. Determine whether the addition of an IGFBP-2 vaccine to neoadjuvant chemotherapy increases progression free survival at 12 months.

2. Determine whether the addition of an IGFBP-2 vaccine to neoadjuvant chemotherapy improves overall survival.

3. To determine whether IGFBP-2 vaccination in combination with chemotherapy increases the level of tumor infiltrating lymphocytes (TIL) in the tumor.

4. To assess the level of IGFBP-2 type 1 helper cells (Th1) elicited with vaccination concurrent with chemotherapy.

EXPLORATORY OBJECTIVES:

1. To explore whether there is a predictive genomic signature for CR induction when IGFBP-2 vaccination is used in combination with chemotherapy.

OUTLINE:

Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine intradermally (ID) 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery.

After completion of study treatment, patients are followed up at 6 months and then once a year for 5 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Concurrent IGFBP-2 Vaccination and Neoadjuvant Chemotherapy to Increase the Rate of Pathologic Complete Response at the Time of Cytoreductive Surgery
• Actual Study Start Date: Apr 3, 2017
• Actual Primary Completion Date: Oct 17, 2018
• Actual Study Completion Date: Dec 10, 2019

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Treatment (chemotherapy, IGFBP-2 vaccine) Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine ID 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery.

Drug: Carboplatin; Given IV; Other Names: Blastocarb Carboplat Carboplatin Hexal Carboplatino Carbosin Carbosol Carbotec CBDCA Displata Ercar JM-8 Nealorin Novoplatinum Paraplatin Paraplatin AQ Paraplatine Platinwas Ribocarbo ; Procedure: Gynecological Surgical Procedure; Undergo cytoreductive surgery; Other Names: gynecologic surgery Gynecologic Surgical Procedure gynecologic surgical procedures gynecological surgery ; Other: Laboratory Biomarker Analysis; Correlative studies; Drug: Paclitaxel; Given IV; Other Names: Anzatax Asotax Bristaxol Praxel Taxol Taxol Konzentrat ; Biological: pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine; Given ID

Outcome Measures

Primary Outcome Measures

1. Rate of Pathologic Complete Response (CR) [At the time of cytoreductive surgery after receiving study treatment (vaccinations given intradermally approximately two weeks after each combination chemotherapy for 3 doses.)]

   The tissue collected at time of cytoreductive surgery, post study treatment, was evaluated by the attending pathologist assigned to look at the tissue for viable tumor cells. The corresponding surgical pathology report was reviewed to evaluate individual pCR (absence of viable tumor cells).

Secondary Outcome Measures

1. Immunohistochemistry (IHC) Staining for CD3, CD4, CD8, and CD27 [At the time of cytoreductive surgery]

   Will be performed and quantitated using published methods and will be correlated with surgical CR by the Man-Whitney U or one-way analysis of variance test depending on the distribution of TIL outcomes.

2. Level of IGFBP-2 Th1 Cells Elicited With Vaccine Assessed by Enzyme-linked Immunosorbent Spot Assay [Up to 6 months after last vaccine]

   Will be correlated to tumor burden at definitive surgery.

3. Level of Tumor Infiltrating Lymphocytes (TIL) in Tumor [At the time of cytoreductive surgery after receiving study treatment (vaccinations given intradermally approximately two weeks after each combination chemotherapy for 3 doses.)]

   Will be assessed by immunohistochemistry (IHC) to determine whether IGFBP-2 vaccination in combination with chemotherapy increases the level of TIL in the tumor. This was done by assessing the level of IGFBP-2 Th1 elicited by study treatment (vaccination concurrent with chemotherapy). we are looking for an increase in TIL.

4. Overall Survival (OS) [Up to 5 years]

   Will be compared between the treatment arms. Large differences in PFS if observed between the treatment groups will be noted and described. Will be plotted by Kaplan-Meier curve, and compared to the survival data reported by Vergote et al which reported median PFS of 12 months and median OS of 30 months for patients treated with neoadjuvant chemotherapy by a log-rank test.

5. Progression Free Survival (PFS) [Up to 12 months]

   Large differences in PFS if observed between the treatment groups will be noted and described. Will be plotted by Kaplan-Meier curve, and compared to the survival data reported by Vergote et al which reported median PFS of 12 months and median overall survival (OS) of 30 months for patients treated with neoadjuvant chemotherapy by a log-rank test.

6. Tumor Burden [At the time of cytoreductive surgery]

   Will be correlated to level of IGFBP-2 Th1 cells.

Other Outcome Measures

1. Predictive Signature of CR Induction When Vaccinated With an IGFBP-2 Vaccine in Combination With Neoadjuvant Chemotherapy Assessed by Whole Exome Sequencing on Vaccinated Patients' Tumors [At the time of cytoreductive surgery]

   Will use the LASSO regularized regression method to generate preliminary data for a predictive signature. Will correlate mutational profiles with primary platinum sensitive, resistance and refractory outcomes, leveraging the Cancer Genome Atlas data publicly available, to determine differences induced by vaccination.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with newly diagnosed advanced stage (III/IV) ovarian cancer (ovarian/fallopian tube/peritoneal cancer) who have been recommended to receive neoadjuvant carboplatin/paclitaxel chemotherapy with subsequent cytoreductive surgery

• 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 cells (WBC) >= 3000/mm^3 within 30 days of enrollment to study

• Hemoglobin (Hgb) >= 10 g/dl within 30 days of enrollment to study

• Hematocrit (Hct) >= 28% within 30 days of enrollment to study

• Serum creatinine =< 2.0 mg/dl or creatinine clearance > 60 ml/min within 30 days of enrollment to study

• Total bilirubin =< 2.5 mg/dl within 30 days of enrollment to study

• Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) =< 3 times upper limit of normal (ULN) within 30 days of enrollment to study

• Blood glucose <1.5 ULN within 30 days of enrollment to study

• All patients who are having sex that can lead to pregnancy must agree to contraception for the duration of the study

• Patients must be at least 18 years of age

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

• History of (non-infectious) pneumonitis that required steroids or current pneumonitis

• Patients with any contraindication to receiving rhuGM-CSF based products

• 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

• Patients who are pregnant or breastfeeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington	United States	98109

Sponsors and Collaborators

• University of Washington
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: John Liao, Fred Hutch/University of Washington Cancer Consortium

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 22, 2020
• Informed Consent Form - Dec 22, 2020

More Information

Publications

None provided.

• Responsible Party: Mary (Nora) Disis, Professor, Department of Medicine, Division of Oncology, University of Washington
• ClinicalTrials.gov Identifier: NCT03029611
• Other Study ID Numbers: 9760; NCI-2017-00034; RG1717017; P30CA015704
• First Posted: Jan 24, 2017
• Last Update Posted: Jan 14, 2022
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Paclitaxel; Carboplatin; Albumin-Bound Paclitaxel

Study Results

Participant Flow

Arm/Group Title	Treatment (Chemotherapy, IGFBP-2 Vaccine)
Arm/Group Description	Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine ID 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery. Carboplatin: Given IV Gynecological Surgical Procedure: Undergo cytoreductive surgery Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine: Given ID
Period Title: Overall Study
STARTED	9
COMPLETED	9
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Treatment (Chemotherapy, IGFBP-2 Vaccine)
Arm/Group Description	Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine ID 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery. Carboplatin: Given IV Gynecological Surgical Procedure: Undergo cytoreductive surgery Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine: Given ID
Overall Participants	9
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	5 55.6%
>=65 years	4 44.4%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	64
Sex: Female, Male (Count of Participants)
Female	9 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	9 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 11.1%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 11.1%
White	7 77.8%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	9 100%

Outcome Measures

1. Primary Outcome

Title	Rate of Pathologic Complete Response (CR)
Description	The tissue collected at time of cytoreductive surgery, post study treatment, was evaluated by the attending pathologist assigned to look at the tissue for viable tumor cells. The corresponding surgical pathology report was reviewed to evaluate individual pCR (absence of viable tumor cells).
Time Frame	At the time of cytoreductive surgery after receiving study treatment (vaccinations given intradermally approximately two weeks after each combination chemotherapy for 3 doses.)

Outcome Measure Data

Analysis Population Description

Review of the pathology report from cytoreductive surgery.

Arm/Group Title	Treatment (Chemotherapy, IGFBP-2 Vaccine)
Arm/Group Description	Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine ID 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery. Carboplatin: Given IV Gynecological Surgical Procedure: Undergo cytoreductive surgery Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine: Given ID
Measure Participants	9
Count of Participants [Participants]	0 0%

2. Secondary Outcome

Title	Immunohistochemistry (IHC) Staining for CD3, CD4, CD8, and CD27
Description	Will be performed and quantitated using published methods and will be correlated with surgical CR by the Man-Whitney U or one-way analysis of variance test depending on the distribution of TIL outcomes.
Time Frame	At the time of cytoreductive surgery

Outcome Measure Data

Analysis Population Description

Target enrollment was not met. Samples were collected but planned laboratory/statistical analyses were not performed due to termination of study, lack of funding, and insufficient enrollment.

Arm/Group Title	Treatment (Chemotherapy, IGFBP-2 Vaccine)
Arm/Group Description	Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine ID 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery. Carboplatin: Given IV Gynecological Surgical Procedure: Undergo cytoreductive surgery Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine: Given ID
Measure Participants	0

3. Secondary Outcome

Title	Level of IGFBP-2 Th1 Cells Elicited With Vaccine Assessed by Enzyme-linked Immunosorbent Spot Assay
Description	Will be correlated to tumor burden at definitive surgery.
Time Frame	Up to 6 months after last vaccine

Outcome Measure Data

Analysis Population Description

Target enrollment was not met. Samples were collected but planned laboratory/statistical analyses were not performed due to termination of study, lack of funding, and insufficient enrollment.

Arm/Group Title	Treatment (Chemotherapy, IGFBP-2 Vaccine)
Arm/Group Description	Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine ID 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery. Carboplatin: Given IV Gynecological Surgical Procedure: Undergo cytoreductive surgery Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine: Given ID
Measure Participants	0

4. Secondary Outcome

Title	Level of Tumor Infiltrating Lymphocytes (TIL) in Tumor
Description	Will be assessed by immunohistochemistry (IHC) to determine whether IGFBP-2 vaccination in combination with chemotherapy increases the level of TIL in the tumor. This was done by assessing the level of IGFBP-2 Th1 elicited by study treatment (vaccination concurrent with chemotherapy). we are looking for an increase in TIL.
Time Frame	At the time of cytoreductive surgery after receiving study treatment (vaccinations given intradermally approximately two weeks after each combination chemotherapy for 3 doses.)

Outcome Measure Data

Analysis Population Description

Target enrollment was not met. Samples were collected but planned laboratory/statistical analyses were not performed due to termination of study, lack of funding, and insufficient enrollment.

Arm/Group Title	Treatment (Chemotherapy, IGFBP-2 Vaccine)
Arm/Group Description	Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine ID 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery. Carboplatin: Given IV Gynecological Surgical Procedure: Undergo cytoreductive surgery Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine: Given ID
Measure Participants	0

5. Secondary Outcome

Title	Overall Survival (OS)
Description	Will be compared between the treatment arms. Large differences in PFS if observed between the treatment groups will be noted and described. Will be plotted by Kaplan-Meier curve, and compared to the survival data reported by Vergote et al which reported median PFS of 12 months and median OS of 30 months for patients treated with neoadjuvant chemotherapy by a log-rank test.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

Target enrollment was not met. The study was terminated. Planned statistical analysis was not performed due to termination of study, lack of funding, and insufficient enrollment.

Arm/Group Title	Treatment (Chemotherapy, IGFBP-2 Vaccine)
Arm/Group Description	Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine ID 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery. Carboplatin: Given IV Gynecological Surgical Procedure: Undergo cytoreductive surgery Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine: Given ID
Measure Participants	9
Alive	6 66.7%
Deceased - passed away after they left the study	3 33.3%

6. Secondary Outcome

Title	Progression Free Survival (PFS)
Description	Large differences in PFS if observed between the treatment groups will be noted and described. Will be plotted by Kaplan-Meier curve, and compared to the survival data reported by Vergote et al which reported median PFS of 12 months and median overall survival (OS) of 30 months for patients treated with neoadjuvant chemotherapy by a log-rank test.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

Target enrollment was not met. The study was terminated. Planned statistical analysis was not performed due to termination of study, lack of funding, and insufficient enrollment.

Arm/Group Title	Treatment (Chemotherapy, IGFBP-2 Vaccine)
Arm/Group Description	Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine ID 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery. Carboplatin: Given IV Gynecological Surgical Procedure: Undergo cytoreductive surgery Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine: Given ID
Measure Participants	9
PFS	2 22.2%
Recurrence	2 22.2%
Deceased - passed away after they left the study	3 33.3%
Status unchanged	2 22.2%

7. Secondary Outcome

Title	Tumor Burden
Description	Will be correlated to level of IGFBP-2 Th1 cells.
Time Frame	At the time of cytoreductive surgery

Outcome Measure Data

Analysis Population Description

Target enrollment was not met. The study was terminated. Planned statistical analysis was not performed due to termination of study, lack of funding, and insufficient enrollment.

Arm/Group Title	Treatment (Chemotherapy, IGFBP-2 Vaccine)
Arm/Group Description	Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine ID 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery. Carboplatin: Given IV Gynecological Surgical Procedure: Undergo cytoreductive surgery Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine: Given ID
Measure Participants	9
Debulking surgery	7 77.8%
Not evaluable	2 22.2%

8. Other Pre-specified Outcome

Title	Predictive Signature of CR Induction When Vaccinated With an IGFBP-2 Vaccine in Combination With Neoadjuvant Chemotherapy Assessed by Whole Exome Sequencing on Vaccinated Patients' Tumors
Description	Will use the LASSO regularized regression method to generate preliminary data for a predictive signature. Will correlate mutational profiles with primary platinum sensitive, resistance and refractory outcomes, leveraging the Cancer Genome Atlas data publicly available, to determine differences induced by vaccination.
Time Frame	At the time of cytoreductive surgery

Outcome Measure Data

Analysis Population Description

Target enrollment was not met. Samples were collected but planned laboratory/statistical analyses were not performed due to termination of study, lack of funding, and insufficient enrollment.

Arm/Group Title	Treatment (Chemotherapy, IGFBP-2 Vaccine)
Arm/Group Description	Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine ID 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery. Carboplatin: Given IV Gynecological Surgical Procedure: Undergo cytoreductive surgery Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine: Given ID
Measure Participants	0

Adverse Events

Time Frame	The Adverse Events were collected after first vaccination and through to 6 months post vaccination.
Adverse Event Reporting Description	We used CTCAE v4.0 for this study. The adverse events reported here include all events regardless of whether they were unrelated and related to study treatment). Please note that these tables record every adverse event for every subject regardless of severity. For example, a subject may have an injection site reaction at each of the three vaccines where another may not. Each one of these injection site reactions is recorded for that one subject.
Arm/Group Title	Treatment (Chemotherapy, IGFBP-2 Vaccine)
Arm/Group Description	Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine ID 2 weeks later. Treatment repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, patients then undergo cytoreductive surgery. Carboplatin: Given IV Gynecological Surgical Procedure: Undergo cytoreductive surgery Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine: Given ID
All Cause Mortality
	Treatment (Chemotherapy, IGFBP-2 Vaccine)
	Affected / at Risk (%)	# Events
Total	3/9 (33.3%)
Serious Adverse Events
	Treatment (Chemotherapy, IGFBP-2 Vaccine)
	Affected / at Risk (%)	# Events
Total	0/9 (0%)
Other (Not Including Serious) Adverse Events
	Treatment (Chemotherapy, IGFBP-2 Vaccine)
	Affected / at Risk (%)	# Events
Total	9/9 (100%)
Blood and lymphatic system disorders
Anemia	5/9 (55.6%)	6
Cardiac disorders
Palpitations	2/9 (22.2%)	2
Gastrointestinal disorders
Diarrhea	1/9 (11.1%)	1
Nausea	2/9 (22.2%)	3
Vomiting	2/9 (22.2%)	3
Constipation	4/9 (44.4%)	5
Abdominal distension	1/9 (11.1%)	1
Abdominal pain	1/9 (11.1%)	1
Ascites	1/9 (11.1%)	1
General disorders
Fatigue	2/9 (22.2%)	3
Edema limbs	1/9 (11.1%)	1
Non-cardiac chest pain	1/9 (11.1%)	1
Pain	5/9 (55.6%)	6
Injection site reaction	4/9 (44.4%)	4
Infections and infestations
Urinary tract infection	2/9 (22.2%)	2
Other Infection	1/9 (11.1%)	1
Wound infection	1/9 (11.1%)	1
Investigations
White blood cell decreased	1/9 (11.1%)	1
Platelet count decreased	1/9 (11.1%)	1
Weight loss	2/9 (22.2%)	2
Creatinine increased	1/9 (11.1%)	1
Metabolism and nutrition disorders
Hypocalcemia	2/9 (22.2%)	2
Hypoalbuminemia	2/9 (22.2%)	2
Musculoskeletal and connective tissue disorders
Arthralgia	3/9 (33.3%)	4
Myalgia	2/9 (22.2%)	2
Bone pain	1/9 (11.1%)	1
Other - leg weakness	1/9 (11.1%)	1
Other - "pulled muscle" in left upper quadrant	1/9 (11.1%)	1
Nervous system disorders
Cognitive disturbance	1/9 (11.1%)	1
Dizziness	1/9 (11.1%)	1
Headache	3/9 (33.3%)	3
Peripheral sensory neuropathy	5/9 (55.6%)	5
Renal and urinary disorders
Cystitis noninfective	1/9 (11.1%)	1
Hematuria	1/9 (11.1%)	1
Acute kidney injury	1/9 (11.1%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnea	1/9 (11.1%)	1
Pleural effusion	2/9 (22.2%)	2
Skin and subcutaneous tissue disorders
Rash acneiform	1/9 (11.1%)	1
Rash maculo-papular	2/9 (22.2%)	2
Alopecia	9/9 (100%)	12
Surgical and medical procedures
Other - paracentisis	4/9 (44.4%)	4
Other - IVC filter placed due to clots	1/9 (11.1%)	1
Other - thoracentesis x 2 due to pleural effusion. Hospitalized	1/9 (11.1%)	1
Other - ex-lap, RSO, omentectomy, appendectomy, tumor debulking	1/9 (11.1%)	1
Vascular disorders
Flushing	2/9 (22.2%)	2
Hypotension	1/9 (11.1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.