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 Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00801320
• Other study ID #: 07-319
• Status: Completed
• Phase: N/A
• Start date: September 2008
• Est. completion date: August 2020

Study information

• Verified date: September 2020
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Peritoneal Cancer
• Peritoneal Neoplasms

Intervention

Procedure:
• Tumor collection
Tumor collected at the time of planned surgery

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Dana-Farber Cancer Institute, Massachusetts General Hospital, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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