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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)


N/A
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

Thank you

Trial Information

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)


- 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.


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

To collect patient tumor samples that could possibly be used in a subsequent clinical vaccine trial (DF/HCC protocol 07-380).

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

David Avigan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Institutional Review Board

Study ID:

07-319

NCT ID:

NCT00801320

Start Date:

September 2008

Completion Date:

August 2012

Related Keywords:

  • Ovarian Cancer
  • Peritoneal Cancer
  • Fallopian Tube Cancer
  • tumor harvest
  • tumor collection
  • tumor storage
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Brigham & Women's Hospital Boston, Massachusetts  02115