We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00801320
First Posted: December 3, 2008
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Dana-Farber Cancer Institute
Massachusetts General Hospital
National Cancer Institute (NCI)
Information provided by (Responsible Party):
David Avigan, MD, Dana-Farber Cancer Institute
  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

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by David Avigan, MD, 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 ]
  • To gain experience in appropriate clinical processing of tumor samples and determining cell yield. [ Time Frame: 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. [ Time Frame: 2 years ]

Estimated Enrollment: 100
Study Start Date: September 2008
Estimated Study Completion Date: December 2018
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00801320


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Massachusetts General Hospital
National Cancer Institute (NCI)
Investigators
Principal Investigator: David Avigan, MD Beth Israel Deaconess Medical Center
  More Information

Responsible Party: David Avigan, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00801320     History of Changes
Other Study ID Numbers: 07-319
First Submitted: December 2, 2008
First Posted: December 3, 2008
Last Update Posted: July 2, 2017
Last Verified: June 2017

Keywords provided by David Avigan, MD, Dana-Farber Cancer Institute:
tumor harvest
tumor collection
tumor storage

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases