Cancer Clinical Trial
Official title:
Request to Conduct Research for Same Use of Stored Human Samples, Specimens, or Data Collected in a Terminated NCI-IRB Protocol
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help
doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This laboratory study is looking at previously collected and stored tissue samples
from patients previously enrolled in a completed National Cancer Institute clinical trial.
OBJECTIVES:
- Conduct research for same use of stored human samples, specimens, and data collected
from patients previously enrolled in a terminated National Cancer
Institute-Institutional Review Board clinical trial.
- Correlate plasma levels and pharmacokinetics with disease burden and presence of
antibodies.
- Correlate tumor markers with disease burden.
- Determine the utility of tumor markers for following patients after treatment.
OUTLINE: Stored human samples, specimens, and data collected from patients previously
enrolled in a terminated National Cancer Institute-Institutional Review Board clinical trial
are analyzed for research studies*. Antibodies are neutralized to allow for correlation of
ELISA assays for immunogenicity with neutralization assays, which require cytotoxicity
assays. In cytotoxicity assays, fresh malignant cells are isolated from blood, bone marrow,
lymph nodes, or other tissues and incubated with recombinant immunotoxins to determine their
sensitivity. Soluble CD25 assays are used to analyze known marker for B-cell malignancies,
particularly those that are CD25-positive. Other candidate tumor markers include soluble
IRTA2, soluble CD22, and soluble mesothelin. Skin biopsies retained by the Clinical Pathology
Lab are used to study capillary leak syndrome. Other research studies include HLA typing to
correlate immunological parameters with response and the PAX-gene tube to obtain RNA for
quantitative PCR, evaluate monoclonal immunoglobulin expression, study minimal residual
disease, and characterize immunoglobulin gene usage and somatic mutation. RNA microarrays are
used to study resistance to immunotoxins. Samples of blood are used to study mechanisms of
hemolytic uremic syndrome (HUS) from anti-CD22 immunotoxins. DNA samples are analyzed for
complement and/or Factor H mutations that would make a patient more susceptible to HUS.
Samples are also analyzed for levels of immunotoxin in blood, urine, and other tissues and
for quantification of tumor markers on malignant cells using flow cytometry assays.
NOTE: *Assays that have significant risk to the patient or to the patient's family, including
genetic cancer susceptibility studies, will not be performed.
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