Study of Previously Collected and Stored Tissue Samples From Patients Previously Enrolled in a Completed National Cancer Institute Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00904514
• Other study ID #: CDR0000573913
• Secondary ID: NCI-08-C-N013P07
• Status: Terminated
• Start date: October 2007
• Est. completion date: October 2007

Study information

• Verified date: February 2012
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 241
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Samples available from patients previously enrolled in one of the following terminated National Cancer Institute-Institutional Review Board clinical trials:

• Phase I study of LMB-2: NCI-96-C-0064; NCI-T95-0042

• Phase I study of BL22: NCI-99-C-0014; NCI-T98-0063

• Phase I study of LMB-9: NCI-98-C-0078; NCI-T98-0005

• Phase I study of LMB-7: NCI-94-C-0172

• Phase I study of bolus SS1P: NCI-03-C-0243

• Phase I study of continuous infusion SS1P: NCI-01-C-0011

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Related Conditions & MeSH terms

• Cancer

Intervention

Genetic:
• gene expression analysis

• microarray analysis

• mutation analysis

• polymerase chain reaction

Other:
• flow cytometry

• immunoenzyme technique

• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analyses of stored human samples, specimens, and data collected from patients previously enrolled in a terminated National Cancer Institute-Institutional Review Board clinical trial
Primary	Correlation of plasma levels and pharmacokinetics with disease burden and presence of antibodies
Primary	Correlation of tumor markers with disease burden
Primary	Utility of tumor markers for following patients after treatment