Study of Previously Collected and Stored Tissue Samples From Patients Previously Enrolled in a Completed National Cancer Institute Clinical Trial
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ClinicalTrials.gov Identifier: NCT00904514 |
Recruitment Status
:
Completed
First Posted
: May 19, 2009
Last Update Posted
: February 20, 2012
|
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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.
Condition or disease | Intervention/treatment |
---|---|
Cancer | Genetic: gene expression analysis Genetic: microarray analysis Genetic: mutation analysis Genetic: polymerase chain reaction Other: flow cytometry Other: immunoenzyme technique Other: laboratory biomarker analysis |
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.
Study Type : | Observational |
Estimated Enrollment : | 241 participants |
Official Title: | Request to Conduct Research for Same Use of Stored Human Samples, Specimens, or Data Collected in a Terminated NCI-IRB Protocol |
Study Start Date : | October 2007 |
Actual Primary Completion Date : | October 2007 |
Actual Study Completion Date : | October 2007 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00904514
Principal Investigator: | Robert Kreitman, MD | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00904514 History of Changes |
Other Study ID Numbers: |
CDR0000573913 NCI-08-C-N013 P07268 |
First Posted: | May 19, 2009 Key Record Dates |
Last Update Posted: | February 20, 2012 |
Last Verified: | February 2012 |
Keywords provided by National Institutes of Health Clinical Center (CC):
recurrent adult Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma Waldenström macroglobulinemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia refractory hairy cell leukemia recurrent small lymphocytic lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma |
recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent adult Burkitt lymphoma stage I adult T-cell leukemia/lymphoma stage II adult T-cell leukemia/lymphoma stage III adult T-cell leukemia/lymphoma stage IV adult T-cell leukemia/lymphoma recurrent adult T-cell leukemia/lymphoma prolymphocytic leukemia recurrent mantle cell lymphoma stage IV mycosis fungoides/Sezary syndrome recurrent mycosis fungoides/Sezary syndrome recurrent marginal zone lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue |