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Terminated NCT00799110

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

Conditions: Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 15
Sponsor: Beth Israel Deaconess Medical Center

Location: Massachusetts General Hospital Boston Massachusetts

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.

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 X 103/uL, Platelets \> 50,000/uL, Bilirubin \< 2.0 mg/dL Creatinine \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT00799110). StuddyBuddy aggregates publicly available trial information.