Collection of Blood From Patients With Cancer - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00034216

Purpose

This study will collect blood from patients with cancer to study the level of cells which decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18 years of age and older with cancer may participate. This study does not involve treatment.

Participants will have about 50 ml (3 tablespoonfuls) of blood drawn. Depending on their condition, patients may be invited to enroll in a clinical research study involving chemotherapy, radiotherapy, or surgery. Additional 40-ml blood samples may be drawn during the course of treatment.

Condition
Neoplasms

Study Type:	Observational
Official Title:	Collection of Blood and Urine From Patients With Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:	250
Study Start Date:	April 2002

Detailed Description:

Patients with a prior diagnosis of malignancy or refractory cancer will be evaluated in the Medical Oncology Clinic, NCI or Interventional Radiology, NIH Clinical Center. Blood or urine samples may be collected at the initial visit and at follow-up visits. Blood samples will be processed and stored in the Laboratory of Tumor Immunology and Biology or Frederick for use in research efforts. Urine samples will be processed and stored by the Clinical Pharmacology Program

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA:

Patients 18 years of age and older are eligible.

Patients must have a performance status of ECOG 0, 1, 2, or 3 for admission to this protocol.

Patients with malignancy are eligible.

INCLUSION FOR APHERESIS:

Hemoglobin greater than or equal to 10 mg/dL and platelet count > 75,000/mm(3)

Weight greater than 25 kg

HIV negative

Prothrombin Time - within normal limits

Partial Thromboplastin Time - within normal limits

Medically indicated central line in place or adequate peripheral venous access

EXCLUSION CRITERIA:

Children will not be eligible.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00034216

Contacts

Contact: NCI Referral Office	1-888-NCI-1937
Contact: Mary P. Pazdur, C.R.N.P.	(301) 496-7870	pazdurm@mail.nih.gov

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892
Sub-Investigator: National Cancer Institute Referral Office For more information at the NIH Clinical Center contact

Sponsors and Collaborators

National Cancer Institute (NCI)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

Shimizu J, Yamazaki S, Sakaguchi S. Induction of tumor immunity by removing CD25+CD4+ T cells: a common basis between tumor immunity and autoimmunity. J Immunol. 1999 Nov 15;163(10):5211-8.

Jonuleit H, Schmitt E, Stassen M, Tuettenberg A, Knop J, Enk AH. Identification and functional characterization of human CD4(+)CD25(+) T cells with regulatory properties isolated from peripheral blood. J Exp Med. 2001 Jun 4;193(11):1285-94.

Levings MK, Sangregorio R, Roncarolo MG. Human cd25(+)cd4(+) t regulatory cells suppress naive and memory T cell proliferation and can be expanded in vitro without loss of function. J Exp Med. 2001 Jun 4;193(11):1295-302.

ClinicalTrials.gov Identifier:	NCT00034216 History of Changes
Other Study ID Numbers:	020179, 02-C-0179
Study First Received:	April 24, 2002
Last Updated:	December 29, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Suppressor Cells
T Cells
CD4+/CD25+ Cells

Cancer
Malignancy
Blood Sample

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on February 12, 2012