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Cancer Vaccine

Cancer Vaccine for Ovarian Cancer

Phase 2

Waitlist Available

Led By David Avigan, MD

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Complete clinical response after first-line chemotherapy for newly-diagnosed patients, or after second-line chemotherapy for relapsed patients who require secondary cytoreduction

Patients must have ECOG performance status of 0-2 with greater than six week life expectancy

Must not have

Patients with a history of clinically significant venous thromboembolism will be excluded

Patients must not have clinically significant autoimmune disease that requires treatment with immunosuppressant medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Summary

This trial is testing a new cancer vaccine made from a person's own dendritic cells. Dendritic cells are powerful immune cells that help the body fight infections. The vaccine will be given with laboratory made agents GM-CSF and imiquimod. Researchers want to see if the vaccine is safe and if it has any effect on the person's cancer.

Who is the study for?

This trial is for patients with stage III or IV ovarian, fallopian tube, or primary peritoneal serous carcinoma who are not showing disease progression after chemotherapy. They must have a life expectancy over six weeks and be able to perform daily activities (ECOG 0-2). Participants need normal blood counts and liver/kidney function tests, should not be pregnant, and cannot have autoimmune diseases requiring immunosuppressants.Check my eligibility

What is being tested?

The study is testing a dendritic cell/tumor fusion vaccine combined with GM-CSF and imiquimod on the immune system of participants. It aims to evaluate the vaccine's impact on cancer as well as its safety profile. Dendritic cells are part of the body's natural defense against foreign substances.See study design

What are the potential side effects?

Potential side effects may include reactions at the injection site, flu-like symptoms such as fever and chills, fatigue, changes in blood pressure or heart rate, allergic responses, muscle pain, headache and possible impacts on white blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer responded completely to initial or second-line chemotherapy.

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I can care for myself and am expected to live more than six weeks.

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My disease is stable and does not need chemotherapy before starting vaccination.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never had a serious blood clot.

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I do not have an autoimmune disease that needs treatment with immunosuppressants.

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My cancer got worse while on first-line platinum/taxane chemotherapy.

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I do not have a serious illness like an infection needing IV antibiotics or major heart problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To determine if cellular immunity is induced by serial vaccination with DC/tumor fusion cells, when given with GM-CSF alone, or the combination of GM-CSF and imiquimod in this patient population.

Secondary outcome measures

To assess clinical response to vaccination with DC/tumor fusion when given with GM-CSF and imiquimod.

To assess toxicity associated with vaccination with DC/tumor fusion when given with GM-CSF and imiquimod.

To correlate immunologic response following vaccination with measures of patient cellular immune function and phenotypic characteristics of the vaccine preparation.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2Experimental Treatment3 Interventions

Vaccine, GM-CSF and imiquimod,

Group II: Group 1Experimental Treatment2 Interventions

Vaccination plus GM-CSF

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GM-CSF

2014

Completed Phase 4

~1340

imiquimod

2008

Completed Phase 3

~750

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor

840 Previous Clinical Trials

13,011,696 Total Patients Enrolled

13 Trials studying Ovarian Cancer

503 Patients Enrolled for Ovarian Cancer

Dana-Farber Cancer InstituteOTHER

1,085 Previous Clinical Trials

341,757 Total Patients Enrolled

40 Trials studying Ovarian Cancer

4,629 Patients Enrolled for Ovarian Cancer

Massachusetts General HospitalOTHER

2,955 Previous Clinical Trials

13,212,655 Total Patients Enrolled

27 Trials studying Ovarian Cancer

4,027 Patients Enrolled for Ovarian Cancer

Media Library

Dendritic Cell/Tumor Fusion Vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT00799110 — Phase 2

Ovarian Cancer Research Study Groups: Group 2, Group 1

Ovarian Cancer Clinical Trial 2023: Dendritic Cell/Tumor Fusion Vaccine Highlights & Side Effects. Trial Name: NCT00799110 — Phase 2

Dendritic Cell/Tumor Fusion Vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00799110 — Phase 2

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