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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 up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~1350
imiquimod
2008
Completed Phase 3
~5200

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
854 Previous Clinical Trials
12,930,928 Total Patients Enrolled
13 Trials studying Ovarian Cancer
503 Patients Enrolled for Ovarian Cancer
Dana-Farber Cancer InstituteOTHER
1,108 Previous Clinical Trials
357,214 Total Patients Enrolled
42 Trials studying Ovarian Cancer
4,738 Patients Enrolled for Ovarian Cancer
Massachusetts General HospitalOTHER
3,013 Previous Clinical Trials
13,309,288 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
~0 spots leftby Dec 2024
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