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

This study is currently recruiting participants.

Verified by Dana-Farber Cancer Institute, December 2008

Sponsors and Collaborators:	Beth Israel Deaconess Medical Center Dana-Farber Cancer Institute Massachusetts General Hospital National Cancer Institute (NCI)
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00801320

Purpose

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	Intervention
Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer	Procedure: Tumor collection

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Open Label, Single Group Assignment
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)

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
To gain experience in appropriate clinical processing of tumor samples and determining cell yield. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	June 2008
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Tumor collected at the time of planned surgery

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801320

Contacts

Contact: Dilani Domabgoda	617-667-5984
Contact: Evan Barnathan	617-667-1946	ebarnath@bidmc.harvard.edu

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Corrine Zarwan, MD
Sub-Investigator: David Avigan, MD
Sub-Investigator: Jacalyn Rosenblatt, MD
Sub-Investigator: Stephen Cannistra, MD
Sub-Investigator: Young Bae Kim, MD
Sub-Investigator: Christpher Awtrey, MD
Sub-Investigator: Panagiotis Konstantinopoulos, MD
Sub-Investigator: Mary Buss, MD
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Ursula Matulonis, MD
Sub-Investigator: Donald Kufe, MD
Sub-Investigator: Suzanne Berlin, MD
Sub-Investigator: Susana Campos, MD
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Carolyn Krasner, MD
Sub-Investigator: Marcela Del Carmen, MD
Brigham & Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Ross Berkowitz, MD 617-732-8843 rberkowitz@partners.org
Sub-Investigator: Ross Berkowitz, MD
Sub-Investigator: Neil Horowitz, MD
Sub-Investigator: Colleen Feltmate, MD

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Dana-Farber Cancer Institute

Massachusetts General Hospital

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Corrine Zarwan, MD

Beth Israel Deaconess Medical Center

More Information

Responsible Party:	Beth Isreal Deaconess Medical Center ( Corrine Zarwan, MD )
Study ID Numbers:	07-319
Study First Received:	December 2, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00801320
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

tumor harvest
tumor collection
tumor storage

Study placed in the following topic categories:

Ovarian cancer
Ovarian Neoplasms
Digestive System Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Abdominal Neoplasms
Fallopian Tube Neoplasms

Fallopian Tube Diseases
Genital Diseases, Female
Digestive System Diseases
Peritoneal Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Fallopian tube cancer
Peritoneal Neoplasms
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009