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Collection of Blood From Patients With Cancer

This study is currently recruiting participants.
Verified May 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00034216
First received: April 24, 2002
Last updated: May 16, 2013
Last verified: May 2013
History of Changes
  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, Tissue 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. The specimens will be processed and stored in one or more of these locations for use in research efforts: Laboratory of Tumor Immunology and Biology, Clinical Pharmacology Program, NCI

Frederick, Dr. Tito Fojo's laboratory and Dr. Jane Trepel's Laboratory.

  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: Mary P Pazdur, C.R.N.P. (301) 496-7870 mp327e@nih.gov
Contact: James L Gulley, M.D. (301) 435-2956 gulleyj@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office     (888) NCI-1937        
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: James L Gulley, M.D. National Cancer Institute (NCI)
  More Information

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

Publications:

ClinicalTrials.gov Identifier: NCT00034216     History of Changes
Other Study ID Numbers: 020179, 02-C-0179
Study First Received: April 24, 2002
Last Updated: May 16, 2013
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 May 16, 2013