Primary Tumor Harvest for the Purpose of Possible Use in a Future Clinical Trial in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

Intervention / Treatment
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* Procedure: Tumor collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Patients with either primary ovarian carcinoma or ovarian carcinoma in first relapse treated with DC/Ovarian tumor cells + GM-CSF | Procedure: Tumor collection<br>* Tumor collected at the time of planned surgery<br>|
| Experimental: Cohort 2<br>Patients with either primary ovarian carcinoma or ovarian carcinoma in first relapse treated with DC/Ovarian tumor cells + GM-CSF and topical Imiquimod at site of vaccination | Procedure: Tumor collection<br>* Tumor collected at the time of planned surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect patient tumor samples that could possibly be used in a subsequent clinical vaccine trial (DF/HCC protocol 07-380). |  | 2 years | 
| To gain experience in appropriate clinical processing of tumor samples and determining cell yield. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tumor harvest, tumor collection, tumor storage