Trial Information

The Natural History of Solid Organ Cancer Stem Cells (SOCSC)

Background:

- Traditional models of cancer metastasis posit that cancer metastases might originate
stochastically in any cancer cell while, the Cancer-Stem-Cell hypothesis suggests that
the metastasizing cells are Solid Organ Cancer Stem Cells (SOCSC).

- SOCSC are relatively resistant to current cancer therapies. Thus, effective treatment
for metastatic cancers might require the targeting of SOCSC.

- Knowledge on SOCSC is chiefly derived from cell lines. However, data suggest vast
differences between cell lines and SOCSC obtained from fresh tumors.

- This protocol is designed to facilitate fresh tissue procurement to study SOCSC.

Primary Objective:

-To study the natural history of SOCSC from various primary and metastatic solid organ
cancers using established phenotypic and functional markers.

Secondary Objectives:

- To analyze SOCSC for potential targets that can be used to design novel cancer
therapies that target cancer stem cells.

- To determine whether SOCSC are present in the blood and/or bone marrow, and study their
quantitative and/or qualitative changes from time of surgical resection to time of
recurrence and/or metastasis.

- To evaluate the potential of SOCSC and their quantitative and/or qualitative changes
over time after surgery, to be used in future studies as biomarkers for the early
detection of cancer recurrence and/or metastases.

- To collect detailed history, demographic, and treatment data as well as perioperative
findings to evaluate potential correlation with the presence or absence of SOCSC.

- To develop an animal model to investigate potential interaction between bone marrow
derived stem cells and solid organ cancers.

- To observe the course of normal stem cells over time in patients who had benign tumors
that do not show evidence of cancer over time.

- To compare the course of normal stem cells with that of stem cells from patients with
solid organ cancers.

- To specifically investigate families with clusters of cancer to determine if there is a
relationship between SOCSC and potential familial genetic mutations specific to a
particular cancer and if present, to compare these genetic abnormalities with
individuals from the same family without cancer.

Eligibility:

- Patients 16 years of age or older with primary or metastatic solid organ cancers
requiring resection or other cancer directed therapy that is deemed in the best
interest of their cancer care.

- Patients with premalignant neoplasms who are scheduled to undergo surgery or biopsy as
part of their diagnostic evaluation.

- Patients must have an ECOG performance score of 0-2.

- Patients must have laboratory and physical examination parameters within acceptable
limits by standard of practice guidelines prior to biopsy or surgery.

Design:

- This is a prospective trial designed to procure SOCSC from various benign and solid
organ cancers tumors (primary or metastatic) and follow their natural history from time
of surgery and or other cancer directed therapy to time of recurrence.

- SOCSC will be isolated using phenotypic and functional markers. Investigations will be
performed on the following tissues: Blood prior and after surgery, tumor and adjacent
normal tissue when available, bone marrow (strictly optional under separate consent),
and peritoneal washings when applicable.

- After surgery blood will be drawn at 1 and 3 months and every 3-6 months thereafter
during the follow-up period (5 years). Bone marrow may be analyzed every six months
during the follow-up period (strictly optional).

- Patients will be followed with standard of care or other cancer directed therapy deemed
in the best interest of the patient.

- It is anticipated that between 274 and 676 patients will be enrolled over a period of 5
years (2-5 patients per month).