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

Primary Purpose

Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GM-CSF
Dendritic Cell/Tumor Fusion Vaccine
imiquimod
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring dendritic cells, fusion vaccines, GM-CSF, imiquimod

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria at time of initial enrollment:

  • 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)
  • Patients with histologically proven stage III or IV ovarian, fallopian tube or primary peritoneal serous carcinoma (or patients of any stage with recurrent disease) who demonstrate lack of disease progression as determined by clinical assessment as well as CA-125 levels and/or radiographic assessment
  • Patients must have ECOG performance status of 0-2 with greater than six week life expectancy.
  • All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines.
  • Laboratories:WBC > 2.0 X 103/uL, Platelets > 50,000/uL, Bilirubin < 2.0 mg/dL, Creatinine <2.0 mg/dL, AST/ALT < 2.5 x ULN

Eligibility criteria prior to first vaccination

At a maximum of twelve weeks after the last dose of chemotherapy, patients must fulfill the following criteria:

  • Complete clinical response after first-line chemotherapy for newly-diagnosed patients, or after second-line chemotherapy for relapsed patients who require secondary cytoreduction.**
  • Asymptomatic, low volume disease not requiring further chemotherapy prior to initiating vaccination

    ** Complete clinical response is defined as normal exam, normal CT scan, and normal CA-125 level. Tumor tissue for relapsed patients would be obtained under informed consent at the time of a secondary surgical debulking, which would be performed as part of standard relapse management in appropriate patients.

  • Resolution of all chemotherapy related grade III-IV toxicity
  • Laboratories:WBC > 2.0 X 103/uL, Platelets > 50,000/uL, Bilirubin < 2.0 mg/dL Creatinine <2.0 mg/dL, AST/ALT < 2.5 x ULN

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)

Sites / Locations

  • Massachusetts General Hospital
  • Brigham & Women's Hospital
  • Dana-Farber Cancer Institute
  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 2

Group 1

Arm Description

Vaccine, GM-CSF and imiquimod,

Vaccination plus GM-CSF

Outcomes

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

Full Information

First Posted
November 26, 2008
Last Updated
June 16, 2023
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital, National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00799110
Brief Title
Vaccination of Patients With Ovarian Cancer With Dendritic Cell/Tumor Fusions With Granulocyte Macrophage Colony-stimulating Factor (GM-CSF) and Imiquimod
Official Title
Vaccination of Patients With Ovarian Cancer With Dendritic Cell/Tumor Fusions With GM-CSF and Imiquimod
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital, National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer
Keywords
dendritic cells, fusion vaccines, GM-CSF, imiquimod

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 2
Arm Type
Experimental
Arm Description
Vaccine, GM-CSF and imiquimod,
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Vaccination plus GM-CSF
Intervention Type
Drug
Intervention Name(s)
GM-CSF
Intervention Description
Injections given subcutaneously at the sight of vaccination on the day of the vaccination and for three days afterwards
Intervention Type
Biological
Intervention Name(s)
Dendritic Cell/Tumor Fusion Vaccine
Other Intervention Name(s)
DC/tumor fusion vaccine
Intervention Description
Given subcutaneously once every three weeks for a total of three vaccines
Intervention Type
Drug
Intervention Name(s)
imiquimod
Intervention Description
Cream applied to the skin at the injection sight 2 hours before injection and for 3 days following the injection
Primary Outcome Measure Information:
Title
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
To assess toxicity associated with vaccination with DC/tumor fusion when given with GM-CSF and imiquimod.
Time Frame
2 years
Title
To assess clinical response to vaccination with DC/tumor fusion when given with GM-CSF and imiquimod.
Time Frame
2 years
Title
To correlate immunologic response following vaccination with measures of patient cellular immune function and phenotypic characteristics of the vaccine preparation.
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria at time of initial enrollment: 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) Patients with histologically proven stage III or IV ovarian, fallopian tube or primary peritoneal serous carcinoma (or patients of any stage with recurrent disease) who demonstrate lack of disease progression as determined by clinical assessment as well as CA-125 levels and/or radiographic assessment Patients must have ECOG performance status of 0-2 with greater than six week life expectancy. All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines. Laboratories:WBC > 2.0 X 103/uL, Platelets > 50,000/uL, Bilirubin < 2.0 mg/dL, Creatinine <2.0 mg/dL, AST/ALT < 2.5 x ULN Eligibility criteria prior to first vaccination At a maximum of twelve weeks after the last dose of chemotherapy, patients must fulfill the following criteria: Complete clinical response after first-line chemotherapy for newly-diagnosed patients, or after second-line chemotherapy for relapsed patients who require secondary cytoreduction.** Asymptomatic, low volume disease not requiring further chemotherapy prior to initiating vaccination ** Complete clinical response is defined as normal exam, normal CT scan, and normal CA-125 level. Tumor tissue for relapsed patients would be obtained under informed consent at the time of a secondary surgical debulking, which would be performed as part of standard relapse management in appropriate patients. Resolution of all chemotherapy related grade III-IV toxicity Laboratories:WBC > 2.0 X 103/uL, Platelets > 50,000/uL, Bilirubin < 2.0 mg/dL Creatinine <2.0 mg/dL, AST/ALT < 2.5 x ULN 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Avigan, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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