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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:
Collaborators:
Dana-Farber Cancer Institute
Massachusetts General Hospital
National Cancer Institute (NCI)
Information provided by (Responsible Party):
David Avigan, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00801320
First received: December 2, 2008
Last updated: August 7, 2012
Last verified: August 2012
History of Changes
  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: Intervention Model: Single Group Assignment
Masking: Open Label
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:

U.S. FDA Resources

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: 100
Study Start Date: September 2008
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00801320

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
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

No publications provided

Responsible Party: David Avigan, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00801320     History of Changes
Other Study ID Numbers: 07-319
Study First Received: December 2, 2008
Last Updated: August 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
tumor harvest
tumor collection
tumor storage

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

ClinicalTrials.gov processed this record on May 21, 2013