Trial Information

Acquisition of Blood and Tumor Tissue Samples From Patients With Gastrointestinal Cancer

BACKGROUND:

- Numerous recent therapeutic advances have changed standard treatment options for
patients with GI cancer. These include newer chemotherapeutic agents in addition to
established proof of principle for anti-angiogenic agents. The burden of GI cancers is
reflected by the presence of three GI cancer types in the top five causes of cancer
mortality. Over 58,000 deaths yearly can be attributed to GI cancer.

- While immune-based therapies in GI cancers are experimental at the current time, a
gathering body of literature is suggestive of an enormous potential, either alone, or
most likely in combination with standard chemotherapy.

- Before immunotherapy can be combined with non-immune based treatment options we first
need to investigate the effects of non-immune based therapies on immune responses
(especially immune-evasive mechanisms) with cancer.

OBJECTIVES:

- To collect blood and/or tumor samples, including pleural and peritoneal fluid, from
patients with gastrointestinal (GI) cancers being reviewed by Medical Oncology Branch
and to perform an analysis of immune subsets with regard to their function and how they
modulate with therapy. Also to collect from patients with non-GI cancers for
comparison.

- To identify new immune suppressor mechanisms

- To collect blood samples from both patients with GI cancer and also age-matched healthy
controls for exploratory quantitative and qualitative analysis of circulating tumor
cells (CTC assay).

ELIGIBILITY:

- Patients undergoing evaluation for participation in NCI treatment protocols in the NCI
intramural program with diagnosis of cancer.

- 18 year of age or older.

DESIGN:

- Blood and/or tumor samples may be collected from consenting subjects at the initial
visit and/or at follow-up visits.

- Analysis of immune function will be performed both at baseline, and at subsequent
visits, if they have follow up at NIH, at up to two additional time points when the
patient returns for follow-up, and end of therapy.

- Blood will also be obtained from patients and healthy controls for CTC analysis.