Protocol Number: 97-C-0143

Title:

Investigation of the Human Immune Response and HTLV-1 Infection

Number:

97-C-0143

Summary:

This protocol is being submitted to consolidate, update, and expand two previously approved protocols (77-C-0066 and 82-C-0044) into a single protocol. The purpose of this study is to examine the factors involved in the regulation of the immune system of healthy individuals and to define the abnormalities in this regulation that underlies the immunological disorders of patients with a variety of immunodeficiency and malignant disorders. The studies will include the ex vivo phenotypic and functional analysis of the network of cells involved in humoral and cellular immune responses, and in vivo testing for the capacity to make delayed-type hypersensitivity and humoral responses following immunization with a variety of antigens. Individuals to be studied will include patients with a variety of malignancies and patients with primary and secondary immunodeficiency disorders. Selected family members or family members known to be genetic carriers of certain immunodeficiency diseases as well as normal, unrelated individuals will also be studied. A small number of procedures will be used including analysis of blood obtained by phlebotomy, apheresis, skin testing and recall antigens and immunization to assess humoral immunity.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

Patient must have a suspected or known disorder of the immune system or malignancy, OR

Be a family member of a patient with a known or suspected immunodeficiency disease, OR

Be a known or potential carrier of genetically determined immunodeficiency disease.

Specific immunodeficiency disorders may include but are not limited to: X-linked SCID (severe combined immunodeficiency) (c gamma deficiency), autosomal recessive SCID, X-linked CD40 ligand deficiency, Common variable immunodeficiency, Ataxia-telangiectasia, Wiskott Aldrich syndrome, and the DiGeorge syndrome OR

Be infected with HTLV-1.

Age of birth and above for patients with suspected or known disorders of the immune system.

Patient (or parent/guardian of a minor child) must be able to understand and sign informed consent.

Hematocrit greater than 28%, and platelet count greater than 50,000 necessary for apheresis.

Subjects for whom apheresis is desired but whose counts are lower than those above must be evaluated and approved by a Department of Transfusion Medicine consult physician.

Weight greater than 25 kg and adequate venous access (not requiring placement of a central catheter) are necessary for apheresis.

EXCLUSION CRITERIA:

Overall Exclusion Criteria:

Pregnant or breast feeding women will not be eligible for any aspect of this protocol except phlebotomy

Exclusion Criteria for skin/parenteral antigen tests:

Any history of severe reaction or allergy to a particular skin test antigen or other ingredients in the formulation (e.g. Thimerosal, eggs or avian protein) will exclude a subject from receiving that particular skin test.

Children under the age of 2 years are not eligible to receive the Pneumococcal polyvalent vaccine.

Subjects under the age of 18 years are not eligible to receive the Candida or mumps skin test antigens.

Exclusion Criteria for Apheresis Alone:

Any diagnosed medical condition which may be worsened by the apheresis procedure. Specifically the patient should not have any of the following:

1. Congestive Heart Failure

2. History of angina

3. Severe hypotension (at the discretion of the patient's physician, the apheresis staff and the attending physician from the Department of Transfusion Medicine (DTM) per DTN Standard Operating Policies.)

4. Poorly controlled hypertension (average baseline blood pressure greater than 160/90)

5. History of a coagulation protein disorder.

Pediatric normal volunteers (less than 18 years) will not undergo apheresis.

Special Instructions:

Currently Not Provided

Keywords:

Immunodeficiency

Genes

Metabolism

Infection

Diagnosis

Recruitment Keyword(s):

None

Condition(s):

Communicable Disease

Immunologic Deficiency Syndrome

Neoplasm

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

Molecular genetic analysis of X-linked hypogammaglobulinemia and isolated growth hormone deficiency

Defective in vitro production of influenza virus specific cytotoxic T lymphocytes in ataxia-telangiectasia

Immunodeficiency disease and malignancy: Various immunologic deficiencies of man and the role of immune processes in the control of malignant disease

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