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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study 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.

Timeline

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

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
839 Previous Clinical Trials
13,011,446 Total Patients Enrolled
13 Trials studying Ovarian Cancer
503 Patients Enrolled for Ovarian Cancer
Dana-Farber Cancer InstituteOTHER
1,082 Previous Clinical Trials
341,624 Total Patients Enrolled
40 Trials studying Ovarian Cancer
4,629 Patients Enrolled for Ovarian Cancer
Massachusetts General HospitalOTHER
2,949 Previous Clinical Trials
13,207,366 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
~1 spots leftby Dec 2024