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....
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00001582.
Background:
- The evaluation of the cells of the immune system and HTLV-1 infection has been a central
focus of the Metabolism Branch for the past 30 years.
- Blood obtained by apheresis or blood drawing, skin biopsies and other tissues will be
evaluated for abnormalities related to immunity, HTLV-1 infection and the immune system.
- Advances in the characterization of acquired genetic changes in tumor samples has
led to insights for the development of targeted therapy of malignancy
Objectives:
- To characterize the molecular biology and immunological features as well as the clinical
course of individuals with suspected or known disorders of the immune system or cancer
- To define the nature of the immunological, genetic and epigenetic abnormalities in the
cells of patients with immunodeficiency diseases associated with infections and/or a
high incidence of malignancy and in patients with cancer.
- To obtain whole blood, plasma and leukocytes, as well as skin, lymph node and bone
marrow biopsies on patients with immunodeficiency or cancer to investigate the immune
system.
Eligibility:
- Subjects with cancer.
- Subjects with immunodeficiency.
- Subjects with HTLV-1 infection.
Design:
-This is a natural history study that permits tissue acquisition for analysis of the immune
system and HTLV-1 infection.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationNational Cancer Institute
Principal InvestigatorThomas Alexander Waldmann
