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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2020-08-31

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.

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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.

Conditions

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Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cohort 1

Patients with either primary ovarian carcinoma or ovarian carcinoma in first relapse treated with DC/Ovarian tumor cells + GM-CSF

Group Type EXPERIMENTAL

Tumor collection

Intervention Type PROCEDURE

Tumor collected at the time of planned surgery

Cohort 2

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

Group Type EXPERIMENTAL

Tumor collection

Intervention Type PROCEDURE

Tumor collected at the time of planned surgery

Interventions

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Tumor collection

Tumor collected at the time of planned surgery

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No