Vaccination of Patients With Ovarian Cancer With Dendritic Cell/Tumor Fusions With Granulocyte Macrophage Colony-stimulating Factor (GM-CSF) and Imiquimod

Phase 2

Active, not recruiting

• Conditions: Ovarian Cancer; Primary Peritoneal Cancer; Fallopian Tube Cancer
• Interventions: Drug: GM-CSF; Biological: Dendritic Cell/Tumor Fusion Vaccine; Drug: imiquimod

• Registration Number: NCT00799110
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

This research study is evaluating the effect (good and bad) of a dendritic cell/tumor fusion vaccine in combination with the laboratory made agents GM-CSF and imiquimod on the participants immune system. Another purpose of this study is to determine the type and severity of any side effects associated with this new study vaccine. We will also be evaluating what effect the vaccine has on the participants cancer. Dendritic cell vaccines have already been tested in clinical trials involving participants with many different types of cancer. Dendritic cells are powerful immune-stimulating cells that are normally found in small amounts in the body and are responsible for immune responses against "foreign" substances that enter the body.

Detailed Description

* Patients must have undergone therapeutic debulking surgery for independent clinical indications and have tissue frozen and stored under sterile conditions as part of protocol 07-319 (Study of Primary Tumor Harvest for the Purpose of Possible Use in a Future Clinical Trial in Patients with Ovarian, Fallopian Tube, or Primary Peritoneal Cancer)

* Participants will be assigned to one of two study groups. Both groups will undergo a procedure known as leukapheresis by which the white blood cells are removed from the participants blood in order to obtain the dendritic cells. Prior to this procedure participants may receive 4 injections of GM-CSF, which helps increase the white blood cell count.

* If enough cells are obtained during the leukapheresis, tumor cells and dendritic cells will then be fused (mixed) together in the laboratory and divided into the appropriate doses for administration.

* Participants assigned to Group 1 will undergo subcutaneous vaccination with the dendritic cell tumor fusion vaccine. On the day of the vaccine and three days afterwards, they will receive GM-CSF injections at the site of the vaccination. Participants will receive a dose of the vaccine every 3 weeks for a total of 3 vaccinations.

* Participants assigned to Group 2 will undergo subcutaneous vaccination with the dendritic cell tumor fusion vaccine. On the day of the vaccine and three days afterwards, they will receive GM-CSF injection at the site of the vaccination. Additionally, imiquimod cream will be applied to the skin at the injection sight 2 hours before the vaccine administration. Participants will continue to apply imiquimod cream at the site of vaccination for 3 days following the injection. Participants will receive a dose of the vaccine every 3 weeks for a total of 3 vaccinations.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-11-26
• Study First Submitted QC: 2008-11-26
• Study First Posted: 2008-11-27
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-11
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 23

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

• Patient with progressive disease during first line chemotherapy with a platinum/taxane combination will be excluded.
• Patients must not have clinically significant autoimmune disease that requires treatment with immunosuppressant medications.
• Because of compromised cellular immunity and limited capacity to respond to vaccination, patients who are HIV+ will be excluded.
• Patients must not have serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, unstable ischemic coronary disease or congestive heart failure.
• Pregnant and/or lactating women will be excluded. Premenopausal patients will undergo pregnancy testing when indicated. Women will practice effective birth control while receiving protocol treatment.
• Patients with a history of clinically significant venous thromboembolism will be excluded.
• Active second malignancy, aside from basal cell or squamous cell carcinoma of the skin (i.e. malignancy not treated with curative intent or diagnosis within the past 2 years)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Dendritic Cell/Tumor Fusion Vaccine	Vaccine, GM-CSF and imiquimod,
Group 1	GM-CSF	Vaccination plus GM-CSF
Group 1	Dendritic Cell/Tumor Fusion Vaccine	Vaccination plus GM-CSF
Group 2	imiquimod	Vaccine, GM-CSF and imiquimod,
Group 2	GM-CSF	Vaccine, GM-CSF and imiquimod,

Primary Outcome Measures

Name	Time	Method
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.	2 years

Secondary Outcome Measures

Name	Time	Method
To assess toxicity associated with vaccination with DC/tumor fusion when given with GM-CSF and imiquimod.	2 years
To assess clinical response to vaccination with DC/tumor fusion when given with GM-CSF and imiquimod.	2 years
To correlate immunologic response following vaccination with measures of patient cellular immune function and phenotypic characteristics of the vaccine preparation.	2 years

Trial Locations

Locations (4)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States