Studying Immune Response in Healthy Volunteers and Patients With Cancer or an Immunodeficiency Disorder - Full Text View

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00899067

Purpose

RATIONALE: Studying samples of blood in the laboratory from patients with cancer or an immunodeficiency disorder may help doctors learn more about the immune response.

PURPOSE: This research study is evaluating immune response in healthy volunteers and patients with cancer or an immunodeficiency disorder.

Condition	Intervention
Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific	Other: laboratory biomarker analysis

Study Type:	Observational
Official Title:	Collection of Blood, Bone Marrow, and Tissue Samples for the Investigation of the Human Immune Response, Lymphoma Biology and HTLV-1 Infection

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Capacity of patients with immunodeficiency and malignant disorders to develop and express humoral and cellular immune responses [ Designated as safety issue: No ]
Immune response in healthy volunteers [ Designated as safety issue: No ]
Collection of plasma and skin tissue from patients and healthy volunteers [ Designated as safety issue: No ]

Estimated Enrollment:	1000
Study Start Date:	June 1998

Detailed Description:

OBJECTIVES:

Evaluate the capacity of patients with immunodeficiency and malignant disorders to develop and express humoral and cellular immune responses to a variety of antigenic materials.
Study the immune response in healthy volunteers as a control population for comparison purposes.
Obtain plasma and skin tissue from patients and healthy volunteers for research purposes.
Obtain tumor and bone marrow biopsies for the establishment of tumor lines in immunodeficient mice in order to characterize the acquired abnormalities associated with malignancy in these samples by analysis of DNA, RNA, and protein, lipid, or carbohydrate products expressed by these cells.

OUTLINE: Patients and participants have blood drawn for determination of serum immunoglobulin and circulating antibody levels, Southern blot analysis of circulating lymphocytes (to test for clonal gene rearrangements), and studies of intracellular signaling pathways. Patients also undergo skin hypersensitivity tests and parenteral antigen tests. Selected patients undergo apheresis and/or skin biopsy.

PROJECTED ACCRUAL: At least 1,000 patients will be accrued in this study.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

One of the following groups:
- Patients with suspected or known disorder of the immune system or malignancy
- Family members of patient
- Known or potential carriers of genetically determined immunodeficiency disease
  - X-linked severe combined immunodeficiency (SCID)
  - Autosomal recessive SCID
  - X-linked CD40 ligand deficiency
  - Common variable immunodeficiency
  - Ataxia-telangectasia
  - Wiskott Aldrich syndrome
  - DiGeorge syndrome
- Healthy volunteers

PATIENT CHARACTERISTICS:

Age

Any age (including from birth onward for patients with immune system disorders)

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Hematocrit > 28% (patients or participants undergoing apheresis)
Platelet count > 50,000/mm3 (patients or participants undergoing apheresis)
No history of coagulation protein disorder (patients or participants undergoing apheresis)

Hepatic

Not specified

Renal

Not specified

Cardiovascular

Patients with any of the following are not eligible for the apheresis part of the study:
- Congestive heart failure
- History of angina
- Severe hypotension
- Poorly controlled hypertension

Other

Not pregnant or nursing
Weight > 25 kg (patients or participants undergoing apheresis)
Adequate venous access (patients or participants undergoing apheresis)

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899067

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Patient Recruitment 888-NCI-1937

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

John E. Janik, MD

NCI - Metabolism Branch;MET

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Ariga T, Nakajima M, Yoshida J, Yamato K, Nagatoshi Y, Yanai F, Caviles AP, Nelson DL, Sakiyama Y. Confirming or excluding the diagnosis of Wiskott-Aldrich syndrome in children with thrombocytopenia of an unknown etiology. J Pediatr Hematol Oncol. 2004 Jul;26(7):435-40.

Jin Y, Mazza C, Christie JR, Giliani S, Fiorini M, Mella P, Gandellini F, Stewart DM, Zhu Q, Nelson DL, Notarangelo LD, Ochs HD. Mutations of the Wiskott-Aldrich Syndrome Protein (WASP): hotspots, effect on transcription, and translation and phenotype/genotype correlation. Blood. 2004 Dec 15;104(13):4010-9. Epub 2004 Jul 29.

Study ID Numbers:	CDR0000078571, NCI-97-C-0143, NCI-77-C-0066, NCI-82-C-0044
Study First Received:	May 9, 2009
Last Updated:	July 21, 2009
ClinicalTrials.gov Identifier:	NCT00899067 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific
unspecified childhood solid tumor, protocol specific

Study placed in the following topic categories:

Human T Cell Leukemia Virus 1
Healthy
Lymphoma
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on September 11, 2009