Collection and Storage of Tissue and Blood Samples From Patients With Cancer

PRIMARY OBJECTIVES:

I. To procure biologic tissues and materials to generate preclinical models of cancer.

OUTLINE:

Tumor tissue and blood samples are procured during procedures that are required for the
patients? clinical management and will be stored via xenograft (transplant to another
species) models or in vitro cell culture for future analysis.

Inclusion Criteria:

- Patients with a histologically or cytologically confirmed diagnosis of cancer who are
being evaluated and/or treated for cancer at participating sites

- Ability to understand and willingness to sign a written informed consent document
indicating their willingness to have their tissue or biologic fluid specimens used for
research as outlined in this protocol

Exclusion Criteria:

- Patients with invasive fungal infections

- Patients with active and/or uncontrolled infections or who are still recovering from
an infection

- Actively febrile patients with uncertain etiology of febrile episode

- All antibiotics should be completed at least 1 week (7 days) prior to collection

- No recurrence of fever or other symptoms related to infection for at least 1 week
(7 days) following completion of antibiotics

- Patients with human immunodeficiency virus (HIV), active or chronic hepatitis (i.e.,
quantifiable hepatitis B virus [HBV]-deoxyribonucleic acid [DNA] and/or positive
hepatitis B surface antigen [HbsAg], quantifiable hepatitis C virus [HCV]-ribonucleic
acid [RNA]) or known history of HCV or HBV without documented resolution; testing for
hepatitis B or other infections for eligibility will be performed only if clinically
indicated

- Tumor tissue or blood collections from patients with benign tumors including desmoid
tumors, carcinoma in situ, or ongoing complete disease response (CR)

- Tumor tissue collected from patients on treatment and demonstrating partial (PR)
or stable disease (SD) response will require pathology confirmation sent to the
coordinating site of viable malignancy and < 90% tumor necrosis; or

- Documentation of clinical progression by the assessing physician

- Blood collection only:

- Blood will not be collected from patients whose disease demonstrates ongoing
partial response or who are currently on treatment with ongoing (i.e., prolonged)
stable disease given the poor rate of model generation from such samples