Status:
ACTIVE_NOT_RECRUITING
Vaccination of Patients With Ovarian Cancer With Dendritic Cell/Tumor Fusions With Granulocyte Macrophage Colony-stimulating Factor (GM-CSF) and Imiquimod
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Conditions:
Ovarian Cancer
Primary Peritoneal Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 syst...
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 Primar...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00799110
Start Date
August 1 2008
End Date
December 1 2024
Last Update
June 11 2024
Active Locations (4)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215