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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
David Avigan, MD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00799110
First received: November 26, 2008
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Primary Peritoneal Cancer
Fallopian Tube Cancer
Drug: GM-CSF
Biological: Dendritic Cell/Tumor Fusion Vaccine
Drug: imiquimod
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vaccination of Patients With Ovarian Cancer With Dendritic Cell/Tumor Fusions With GM-CSF and Imiquimod

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess toxicity associated with vaccination with DC/tumor fusion when given with GM-CSF and imiquimod. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To assess clinical response to vaccination with DC/tumor fusion when given with GM-CSF and imiquimod. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To correlate immunologic response following vaccination with measures of patient cellular immune function and phenotypic characteristics of the vaccine preparation. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 23
Study Start Date: August 2008
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 2
Vaccine, GM-CSF and imiquimod,
Drug: GM-CSF
Injections given subcutaneously at the sight of vaccination on the day of the vaccination and for three days afterwards
Biological: Dendritic Cell/Tumor Fusion Vaccine
Given subcutaneously once every three weeks for a total of three vaccines
Other Name: DC/tumor fusion vaccine
Drug: imiquimod
Cream applied to the skin at the injection sight 2 hours before injection and for 3 days following the injection
Experimental: Group 1
Vaccination plus GM-CSF
Drug: GM-CSF
Injections given subcutaneously at the sight of vaccination on the day of the vaccination and for three days afterwards
Biological: Dendritic Cell/Tumor Fusion Vaccine
Given subcutaneously once every three weeks for a total of three vaccines
Other Name: DC/tumor fusion vaccine

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799110

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Investigators
Principal Investigator: David Avigan, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: David Avigan, MD, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00799110     History of Changes
Other Study ID Numbers: 07-380
Study First Received: November 26, 2008
Last Updated: July 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
dendritic cells
fusion vaccines
GM-CSF
imiquimod

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on July 29, 2014