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Completed

NCT Number: NCT00801320

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tumor collection

Procedure

Tumor collected at the time of planned surgery

Primary outcomes

  1. 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

  2. To gain experience in appropriate clinical processing of tumor samples and determining cell yield.

    Time frame: 2 years

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Dana-Farber Cancer Institute
  • Massachusetts General Hospital
  • National Cancer Institute (NCI)

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2020
Study completion
2020
First posted
Dec 3, 2008
Registry last updated
Sep 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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