NCT00801320CompletedNot Applicable
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)
Beth Israel Deaconess Medical Center8 sites in 1 country100 target enrollmentStarted: September 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 8
- Primary Endpoint
- To collect patient tumor samples that could possibly be used in a subsequent clinical vaccine trial (DF/HCC protocol 07-380).
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
To collect patient tumor samples that could possibly be used in a subsequent clinical vaccine trial (DF/HCC protocol 07-380).
Time Frame: 2 years
To gain experience in appropriate clinical processing of tumor samples and determining cell yield.
Time Frame: 2 years
Secondary Outcomes
- 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.(2 years)
Investigators
David Avigan, MD
Principal Investigator
Dana-Farber Cancer Institute
Study Sites (8)
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