IGFBP-2 Vaccine + Carboplatin for Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new vaccine targeting a protein found in ovarian cancer cells. The vaccine, named pUMVC3-hIGFBP-2 Multi-epitope Plasmid DNA Vaccine, is administered after a dose of carboplatin, a chemotherapy drug, to determine if it can prevent the cancer from spreading or worsening in patients with recurrence signs in their blood tests after previous treatment. It is intended for those with ovarian, fallopian tube, or primary peritoneal cancer who have received platinum-based chemotherapy and now exhibit increasing cancer markers in their blood but no visible tumors. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are on systemic steroid therapy above a certain dose or if you have received certain treatments recently. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the IGFBP-2 vaccine is likely safe for patients. Previous studies focused on its safety and suggest that most patients tolerate it well.
Earlier research noted only mild side effects, such as redness at the injection site or slight tiredness, which are common and expected with vaccines. No serious side effects were directly linked to the vaccine.
Carboplatin, a chemotherapy drug used for many years, is well-understood and considered safe under a doctor's care.
Overall, both the IGFBP-2 vaccine and carboplatin have demonstrated good safety records in past studies.12345Why do researchers think this study treatment might be promising?
Researchers are excited about the IGFBP-2 vaccine with carboplatin for ovarian cancer because it offers a novel approach compared to traditional chemotherapy. While standard treatments often rely on broad-acting chemotherapy drugs, this treatment uniquely combines carboplatin with a targeted vaccine that stimulates the immune system to recognize and attack cancer cells expressing the IGFBP-2 protein. This dual approach not only aims to enhance the effectiveness of carboplatin but also provides a more personalized treatment strategy, potentially leading to better outcomes and fewer side effects. The integration of a vaccine into ovarian cancer treatment is an innovative step that holds promise for improving patient responses and long-term survival rates.
What evidence suggests that the IGFBP-2 vaccine and carboplatin treatment might be effective for ovarian cancer?
In this trial, participants will receive a combination of the IGFBP-2 vaccine and carboplatin. Research suggests that the IGFBP-2 vaccine might help the immune system identify and destroy ovarian cancer cells, as IGFBP-2 is a protein often present in these cells, making it an easy target. Combining this vaccine with carboplatin, a chemotherapy drug that can also enhance the immune system, may increase treatment effectiveness. Studies with previous patients have shown that this combination might help prevent cancer from returning or worsening. Although still under investigation, early results indicate that this method could be promising for treating ovarian cancer.12567
Who Is on the Research Team?
John Liao, MD, PhD
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Are You a Good Fit for This Trial?
This trial is for adults with ovarian, fallopian tube, or primary peritoneal cancer whose recurrence has only been detected by blood tests after prior platinum chemotherapy. Participants must have good organ function and no measurable tumors on scans. People with active infections, autoimmune diseases needing treatment, or other cancers can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of carboplatin followed by IGFBP-2 vaccine intradermally on day 1 of each cycle. Cycles repeat every 4 weeks for up to 3 cycles.
Extension
Participants who complete the original vaccine series may receive up to an additional 3 IGFBP-2 vaccines, after another dose of carboplatin, 18 months after first vaccination.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion.
What Are the Treatments Tested in This Trial?
Interventions
- pUMVC3-hIGFBP-2 Multi-epitope Plasmid DNA Vaccine
Trial Overview
The study is testing if an IGFBP-2 DNA vaccine given after a single dose of carboplatin can help the immune system stop ovarian cancer from getting worse in patients who show signs of recurrence only in blood tests. Imaging and lab samples are also collected to monitor progress.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive a single dose carboplatin IV per standard of care on day -3 or -2 of cycle 1. Patients then receive IGFBP-2 vaccine intradermally on day 1 of each cycle. Cycles repeat every 4 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients who complete the original vaccine series may be eligible for up to an additional 3 IGFBP-2 vaccines, after another dose of carboplatin, 18 months after first vaccination. Additionally, patients undergo blood sample collection, CT, and/or MRI throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
The Wayne D. Kuni and Joan E. Kuni Foundation
Collaborator
Citations
IGFBP-2 Vaccine to Prevent Ovarian Cancer Progression ...
Giving the IGFBP-2 vaccine after a single dose of carboplatin may be an effective way to stop ovarian cancer from progressing in patients with serologic ...
Immunization with a plasmid DNA vaccine encoding the N ...
This single arm phase I study had a primary objective to assess the safety of a Th1 selective polyepitope plasmid-based vaccine, pUMVC3-hIGFBP-2 (1-163), ...
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ctv.veeva.com
ctv.veeva.com/study/igfbp-2-vaccine-and-combination-chemotherapy-in-treating-patients-with-stage-iii-iv-ovarian-fallopiIGFBP-2 Vaccine and Combination Chemotherapy in Treating ...
Giving IGFBP-2 vaccine and combination chemotherapy may work better in treating patients with stage III-IV ovarian, fallopian tube, or primary ...
IGFBP-2 Vaccine + Carboplatin for Ovarian Cancer
IGFBP-2 is a protein found in ovarian cancer cells. The IGFBP-2 vaccine may help the body build an effective immune response to kill tumor cells. Carboplatin is ...
Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3 ...
The purpose of this phase 2 study is to assess the efficacy and safety for adjuvant therapeutic cancer vaccine AST-201 (pUMVC3-hIGFBP-2) in patients with newly ...
pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine ...
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 ...
Trial | NCT01322802
This phase I trial is studying the side effects of vaccine therapy in treating patients with stage III-IV or recurrent ovarian cancer.
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