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

NCT ID: NCT00904514

Last Updated: 2018-10-05

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 241 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2007-10-31

Brief 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.

Detailed 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.

Conditions

Cancer

Interventions

gene expression analysis

Intervention Type: GENETIC

microarray analysis

Intervention Type: GENETIC

mutation analysis

Intervention Type: GENETIC

polymerase chain reaction

Intervention Type: GENETIC

flow cytometry

Intervention Type: OTHER

immunoenzyme technique

Intervention Type: OTHER

laboratory biomarker analysis

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role: lead

Principal Investigators

Robert Kreitman, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Other Identifiers

NCI-08-C-N013

Identifier Type: -

Identifier Source: secondary_id

P07268

Identifier Type: -

Identifier Source: secondary_id

CDR0000573913

Identifier Type: -

Identifier Source: org_study_id