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

Sponsor

Beth Israel Deaconess Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00801320

Collaborator

Dana-Farber Cancer Institute (Other), Massachusetts General Hospital (Other), National Cancer Institute (NCI) (NIH)

100

Enrollment

Locations

Arms

143

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer	Procedure: Tumor collection	N/A

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

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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)

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Aug 1, 2020

Actual Study Completion Date :

Aug 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 Patients with either primary ovarian carcinoma or ovarian carcinoma in first relapse treated with DC/Ovarian tumor cells + GM-CSF	Procedure: Tumor collection Tumor collected at the time of planned surgery
Experimental: 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	Procedure: Tumor collection Tumor collected at the time of planned surgery

Arm

Intervention/Treatment

Experimental: Cohort 1

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

Procedure: Tumor collection

Tumor collected at the time of planned surgery

Experimental: 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

Procedure: Tumor collection

Tumor collected at the time of planned surgery

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
2	Brigham & Women's Hospital	Boston	Massachusetts	United States	02115
3	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
4	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215