Trial Information

Collection of Blood, Bone Marrow, Tumor, or Tissue Samples From Patients With Cancer or Normal Volunteers

Background:

Ongoing research in the Experimental and Molecular Therapeutics Sections, NCI, requires the
availability of blood, serum, tumor, hair follicle and tissue samples from patients with
cancer.

Resistance is the underlying cause of treatment failure, and may present as acquired or
intrinsic drug resistance. Patients with cancer frequently present with
chemotherapy-responsive disease, and undergo tumor response, only to eventually experience
relapse, at which time the tumor may be refractory to further treatment. This is termed
acquired drug resistance; while intrinsic resistance implies a cancer that is refractory
from the outset. Diverse mechanisms of drug resistance have been described and are often
dependent upon the particular drug under study.

Objectives:

To obtain blood, serum, tumor, hair follicle or normal tissue samples that would allow
development of assays for use in subsequent clinical trials

Eligibility:

Patients with a prior diagnosis of malignancy, with advanced or refractory cancer will be
evaluated in the Medical Oncology Clinic, NCI.

Blood samples or hair follicle samples may be collected at the initial visit, and at follow
up visits.

Tumor samples may be obtained by fine needle aspirate, by removal of pleural or peritoneal
fluid, or by excisional biopsy, providing the tumor is accessible with a minimal risk to the
patient.

Patients may be on, or in the process of being evaluated for a research protocol.

Patients may receive treatment on the standard care protocol.

Normal volunteers may enroll in the study for collection of blood or hair follicle samples.

Design:

Acquired samples will be recorded in the computerized data bank currently existing in the
Molecular Therapeutics Section. No germline testing will be performed on any of the samples
collected. Tests will be pilot studies relating to the Section's work on the biology of drug
resistance and cell survival in cancer. If any research tests are considered to be
themselves of more than minimal risk to the patient, separate permission will be requested
from the IRB to perform that test, and a new consent will be obtained.

Examples of the types of studies to be performed with biopsies will be drug resistance gene
expression assays, with the goal of demonstrating the utility of the assay in patient
samples.

Evaluation of methods to detect drug resistance proteins and genes will be explored,
including Northern blot, immunoblot, polymerase chain reaction assay, and RNA in situ
hybridization. With whole blood, we may evaluate the presence of dye transport in an ex vivo
assay, for example, using inhibitors of ABCG2. Evidence of drug accumulation or DNA damage
may be sought in patient mononuclear cells or in hair follicle samples.