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

Not Applicable

Completed

• Conditions: Fallopian Tube Cancer; Peritoneal Cancer; Ovarian Cancer
• Interventions: Procedure: Tumor collection

• Registration Number: NCT00801320
• Lead Sponsor: Beth Israel Deaconess Medical Center

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 Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-12-02
• Study First Submitted QC: 2008-12-02
• Study First Posted: 2008-12-03
• Primary Completion: 2020-08
• Study Completion: 2020-08
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-09
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 1	Tumor collection	Patients with either primary ovarian carcinoma or ovarian carcinoma in first relapse treated with DC/Ovarian tumor cells + GM-CSF
Cohort 2	Tumor collection	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (4)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States