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

Background:

- Gastrointestinal cancers can occur in the throat, stomach, gallbladder, liver, pancreas, and colon. Researchers are interested in evaluating how active the immune system is in trying to fight the cancer by studying blood and tumor tissue donated from individuals who have been diagnosed with gastrointestinal cancers.

Objectives:

- To collect blood and tumor samples from individuals who have been diagnosed with gastrointestinal cancers in order to study the immune system's response to the cancer.

Eligibility:

- Individuals at least 18 years of age who have been diagnosed with throat, stomach, gallbladder, liver, pancreatic, or colon cancer, and are scheduled to be treated at the National Institutes of Health.

Design:

• The study will require at least one but no more than four visits to the National Institutes of Health Clinical Center.
• Participants will be screened with a physical examination and medical history, and will provide a baseline blood sample for study.
• Participants will provide additional blood samples 2 and 4 months after the baseline sample, as well as a final sample at the completion of the treatment protocol.
• Participants will provide tumor tissue samples only if they undergo a surgical procedure related to the treatment for their gastrointestinal cancer.
• No treatment will be provided as part of this protocol.

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.

• Gastrointestinal Neoplasms
• Cancer of Gastrointestinal Tract
• Cancer of the Gastrointestinal Tract
• Gastrointestinal Cancer
• Neoplasms, Gastrointestinal

• Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20.
• Greten TF, Ormandy LA, Fikuart A, Höchst B, Henschen S, Hörning M, Manns MP, Korangy F. Low-dose cyclophosphamide treatment impairs regulatory T cells and unmasks AFP-specific CD4+ T-cell responses in patients with advanced HCC. J Immunother. 2010 Feb-Mar;33(2):211-8.
• Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, Berlin J, Baron A, Griffing S, Holmgren E, Ferrara N, Fyfe G, Rogers B, Ross R, Kabbinavar F. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004 Jun 3;350(23):2335-42.
• Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin. 2010 Sep-Oct;60(5):277-300. Epub 2010 Jul 7.

• INCLUSION CRITERIA:
• Patients 18 years of age and older
• Patients with a diagnosis of cancer
• Patients must be willing to provide informed consent

EXCLUSION CRITERIA:

-Children less than 18 years old are not eligible