Brief Title
Primary Tumor Harvest for the Purpose of Possible Use in a Future Clinical Trial in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Official Title
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 (Ovarian Spore)
Brief Summary
The purpose of this research study is to collect tumor samples at the time of surgery and
store them for possible use as part of an experimental vaccine study for the participants
cancer in the future.
Detailed Description
- Even if tumor sample is collected, the participant is under no obligation to participate
in the vaccine study.
- Participants will have their regularly planned surgery as described by their surgeon.
During the surgery, tumor samples will be collected. We will only collect tumor that is
not needed and could otherwise be thrown away.
- The tumor samples will be frozen and placed in storage for up to two years.
Study Type
Interventional
Primary Outcome
To collect patient tumor samples that could possibly be used in a subsequent clinical vaccine trial (DF/HCC protocol 07-380).
Secondary Outcome
Based on feasibility of collection of blood samples of subjects, quantification of T cell subsets, regulatory T cells, activated memory effector cells, and DC phenotype at pre-surgery and post-surgery time points.
Condition
Ovarian Cancer
Intervention
Tumor collection
Study Arms / Comparison Groups
Cohort 1
Description: Patients with either primary ovarian carcinoma or ovarian carcinoma in first relapse treated with DC/Ovarian tumor cells + GM-CSF
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
100
Start Date
September 2008
Completion Date
August 2020
Primary Completion Date
August 2020
Eligibility Criteria
Inclusion Criteria:
- Clinical suspicion of advanced ovarian, fallopian tube or primary peritoneal cancer as
determined by a gynecologic oncologist
- Patients are planning to undergo primary or secondary debulking surgery as part of
standard of care for their disease
- Estimated life expectancy of 6 months or greater
- 18 years of age or older
Exclusion Criteria:
- More than one prior chemotherapy regimen
- 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
- Known HIV infection
- Active second malignancy, aside from basal cell or squamous cell carcinoma of the skin
- Significant autoimmune disease, including psoriasis
- History of clinically significant venous thromboembolism
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
David Avigan, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00801320
Organization ID
07-319
Responsible Party
Principal Investigator
Study Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Dana-Farber Cancer Institute
Study Sponsor
David Avigan, MD, Principal Investigator, Beth Israel Deaconess Medical Center
Verification Date
September 2020