26 Participants NeededMy employer runs this trial

IGFBP-2 Vaccine + Carboplatin for Ovarian Cancer

CC
Overseen ByCVI Coordinators
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Why 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?

JL

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

CA-125 increased to more than twice the upper limit of normal or two times the nadir value after most recent second or later line of treatment
Serum creatinine ≤ 2.0 mg/dl or creatinine clearance > 60 mL/min (performed within 14 days of treatment initiation)
White blood cell (WBC) ≥ 3000/mm^3 (performed within 14 days of treatment initiation)
See 13 more

Exclusion Criteria

I have an autoimmune disease needing strong medication in the past 2 years.
I have not had recent cancer treatment or major surgery in the last 2 weeks, and I have recovered from any side effects.
Has known active hepatitis B (e.g., hepatitis B virus surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis c virus [HCV] ribonucleic acid [qualitative] is detected)
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

12 weeks
4 visits (in-person)

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.

18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment completion.

4 weeks, then every 4 weeks for 1 year, and every 6 months for 2 years

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

Group I: Treatment (carboplatin, IGFBP-2 vaccine)Experimental Treatment5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

The Wayne D. Kuni and Joan E. Kuni Foundation

Collaborator

Trials
4
Recruited
80+

Citations

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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.