Vaccination of Patients With Ovarian Cancer With Dendritic Cell/Tumor Fusions With Granulocyte Macrophage Colony-stimulating Factor (GM-CSF) and Imiquimod
Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring dendritic cells, fusion vaccines, GM-CSF, imiquimod
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)
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
Experimental
Experimental
Group 2
Group 1
Vaccine, GM-CSF and imiquimod,
Vaccination plus GM-CSF