CancerNCT00904514
Study of Previously Collected and Stored Tissue Samples From Patients Previously Enrolled in a Completed National Cancer Institute Clinical Trial
An observational study of Cancer, run by National Institutes of Health Clinical Center (CC).
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Cancer
- What is being tested?
- gene expression analysis, microarray analysis and mutation analysis
- How many people
- 241 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Oct 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
About this study
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.
Read the 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
- Being tested
- gene expression analysis, microarray analysis, mutation analysis, polymerase chain reaction, flow cytometry
- Keywords
- 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
- Medical subject headings
- Neoplasms, Hodgkin Disease, Lymphoma, T-Cell, Cutaneous, Waldenstrom Macroglobulinemia, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Hairy Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene expression analysisGenetic
microarray analysisGenetic
mutation analysisGenetic
polymerase chain reactionGenetic
flow cytometryOther
immunoenzyme techniqueOther
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study startOct 2007
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 241 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Robert Kreitman, MD, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904514
- Sponsor's protocol ID
- CDR0000573913
- Other IDs
- NCI-08-C-N013, P07268
- Status last verified
- Feb 2012
- First submitted
- 16 May 2009
- Last updated
- 5 Oct 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Request to Conduct Research for Same Use of Stored Human Samples, Specimens, or Data Collected in a Terminated NCI-IRB Protocol
- ClinicalTrials.gov ID
- NCT00904514
- Acronym / sponsor ID
- CDR0000573913
- Conditions
- Cancer
- Keywords
- 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
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 241 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 19 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gene expression analysis | Genetic | – |
| microarray analysis | Genetic | – |
| mutation analysis | Genetic | – |
| polymerase chain reaction | Genetic | – |
| flow cytometry | Other | – |
| immunoenzyme technique | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Kreitman, MD principal investigator
National Cancer Institute (NCI)
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by National Institutes of Health Clinical Center (CC).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyses of stored human samples, specimens, and data collected from patients previously enrolled in a terminated National Cancer Institute-Institutional Review Board clinical trial. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2018.