Stage III Fallopian Tube CancerPhase 2NCT03029611
IGFBP-2 Vaccine and Combination Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Undergoing Surgery
A Phase 2 study testing Carboplatin, Gynecological Surgical Procedure and Laboratory Biomarker Analysis in people with Stage III Fallopian Tube Cancer and Stage III Ovarian Cancer, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stage III Fallopian Tube Cancer, Stage III Ovarian Cancer, Stage III Primary Peritoneal Cancer
- What is being tested?
- Carboplatin, Gynecological Surgical Procedure and Laboratory Biomarker Analysis
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2017to 10 Dec 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine whether the addition of an IGFBP-2 vaccine to neoadjuvant chemotherapy increases the rate of complete pathologic response (CR).
SECONDARY OBJECTIVES:
- Determine whether the addition of an IGFBP-2 vaccine to neoadjuvant chemotherapy increases progression free survival at 12 months.
II. Determine whether the addition of an IGFBP-2 vaccine to neoadjuvant chemotherapy improves overall survival.
III. To determine whether IGFBP-2 vaccination in combination with chemotherapy increases the level of tumor infiltrating lymphocytes (TIL) in the tumor.
IV. To assess the level of IGFBP-2 type 1 helper cells (Th1) elicited with vaccination concurrent with chemotherapy.
EXPLORATORY OBJECTIVES:
- 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.
- Conditions
- 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
- Being tested
- Carboplatin, Gynecological Surgical Procedure, Laboratory Biomarker Analysis, Paclitaxel, pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino
Given IV
Gynecological Surgical ProcedureProcedure or surgery
Also called gynecologic surgery, Gynecologic Surgical Procedure, gynecologic surgical procedures, gynecological surgery
Undergo cytoreductive surgery
Laboratory Biomarker AnalysisOther
Correlative studies
PaclitaxelDrug
Also called Anzatax, Asotax, Bristaxol, Praxel
Given IV
pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA VaccineBiological
Given ID
| Study group | Role | What they receive |
|---|---|---|
| Treatment (chemotherapy, IGFBP-2 vaccine) | Experimental | 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. Receives: Drug: Carboplatin; Procedure: Gynecological Surgical Procedure; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Biological: pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Pathologic Complete Response (CR)
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).
Measured: At the time of cytoreductive surgery after receiving study treatment (vaccinations given intradermally approximately two weeks after each combination chemotherapy for 3 doses.)
Secondary outcomes (6)
Immunohistochemistry (IHC) Staining for CD3, CD4, CD8, and CD27
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.
Measured: At the time of cytoreductive surgery
Level of IGFBP-2 Th1 Cells Elicited With Vaccine Assessed by Enzyme-linked Immunosorbent Spot Assay
Will be correlated to tumor burden at definitive surgery.
Measured: Up to 6 months after last vaccine
Level of Tumor Infiltrating Lymphocytes (TIL) in Tumor
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.
Measured: At the time of cytoreductive surgery after receiving study treatment (vaccinations given intradermally approximately two weeks after each combination chemotherapy for 3 doses.)
Overall Survival (OS)
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.
Measured: Up to 5 years
Progression Free Survival (PFS)
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.
Measured: Up to 12 months
Tumor Burden
Will be correlated to level of IGFBP-2 Th1 cells.
Measured: At the time of cytoreductive surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start3 Apr 2017
- Primary completion17 Oct 2018
- Study completion10 Dec 2019
Why it stopped: Terminated due to lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stage III Fallopian Tube CancerStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Mary (Nora) Disis, University of Washington
- Investigators
- John Liao, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029611
- Sponsor's protocol ID
- 9760
- Other IDs
- NCI-2017-00034, RG1717017, P30CA015704
- Status last verified
- Dec 2021
- First submitted
- 10 Jan 2017
- Last updated
- 14 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03029611
- Acronym / sponsor ID
- 9760
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to lack of funding
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 17 Oct 2018 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 24 Jan 2017 (estimated)
- Results
- Posted 14 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- Determine whether the addition of an IGFBP-2 vaccine to neoadjuvant chemotherapy increases the rate of complete pathologic response (CR).
SECONDARY OBJECTIVES:
- Determine whether the addition of an IGFBP-2 vaccine to neoadjuvant chemotherapy increases progression free survival at 12 months.
II. Determine whether the addition of an IGFBP-2 vaccine to neoadjuvant chemotherapy improves overall survival.
III. To determine whether IGFBP-2 vaccination in combination with chemotherapy increases the level of tumor infiltrating lymphocytes (TIL) in the tumor.
IV. To assess the level of IGFBP-2 type 1 helper cells (Th1) elicited with vaccination concurrent with chemotherapy.
EXPLORATORY OBJECTIVES:
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (chemotherapy, IGFBP-2 vaccine) | Experimental | Drug: Carboplatin, Procedure: Gynecological Surgical Procedure, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Biological: pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA VaccinePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (12 listed)
- Patients with any of the following cardiac conditions:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarboplatinAlso: Blastocarb, Carboplat, Carboplatin Hexal, CarboplatinoGiven IV | Drug | Treatment (chemotherapy, IGFBP-2 vaccine) |
| Gynecological Surgical ProcedureAlso: gynecologic surgery, Gynecologic Surgical Procedure, gynecologic surgical procedures, gynecological surgeryUndergo cytoreductive surgery | Procedure or surgery | Treatment (chemotherapy, IGFBP-2 vaccine) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (chemotherapy, IGFBP-2 vaccine) |
| PaclitaxelAlso: Anzatax, Asotax, Bristaxol, PraxelGiven IV | Drug | Treatment (chemotherapy, IGFBP-2 vaccine) |
| pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA VaccineGiven ID | Biological | Treatment (chemotherapy, IGFBP-2 vaccine) |
Primary outcome
Rate of Pathologic Complete Response (CR)
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.)
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).
6 secondary outcomes
Immunohistochemistry (IHC) Staining for CD3, CD4, CD8, and CD27
Time frame: At the time of cytoreductive surgery
Level of IGFBP-2 Th1 Cells Elicited With Vaccine Assessed by Enzyme-linked Immunosorbent Spot Assay
Time frame: Up to 6 months after last vaccine
Level of Tumor Infiltrating Lymphocytes (TIL) in Tumor
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.)
Overall Survival (OS)
Time frame: Up to 5 years
Progression Free Survival (PFS)
Time frame: Up to 12 months
Tumor Burden
Time frame: At the time of cytoreductive surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Liao principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carboplatin, Gynecological Surgical Procedure and Laboratory Biomarker Analysis in people with Stage III Fallopian Tube Cancer and Stage III Ovarian Cancer, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Pathologic Complete Response (CR) (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.)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.