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Request to Conduct Research for Same Use of Stored Human Samples, Specimens, or Data Collected in a Terminated NCI-IRB Protocol


N/A
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

Request to Conduct Research for Same Use of Stored Human Samples, Specimens, or Data Collected in a Terminated NCI-IRB Protocol


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.

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

Type of Study:

Observational

Study Design:

N/A

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

Safety Issue:

No

Principal Investigator

Robert Kreitman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000573913

NCT ID:

NCT00904514

Start Date:

October 2007

Completion Date:

October 2007

Related Keywords:

  • Cancer
  • 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
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • stage IV colon cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • stage IV gastric cancer
  • recurrent gastric cancer
  • recurrent non-small cell lung cancer
  • recurrent pancreatic cancer
  • recurrent colon cancer
  • stage IV esophageal cancer
  • recurrent esophageal cancer
  • recurrent bladder cancer
  • stage IV bladder cancer
  • recurrent ovarian epithelial cancer
  • epithelial mesothelioma
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent salivary gland cancer
  • recurrent squamous cell carcinoma of the nasopharynx
  • stage III cervical cancer
  • recurrent cervical cancer
  • stage IVB cervical cancer
  • stage IVA cervical cancer
  • squamous cell lung cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • advanced malignant mesothelioma
  • recurrent malignant mesothelioma
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent metastatic squamous neck cancer with occult primary
  • ovarian undifferentiated adenocarcinoma
  • ovarian mixed epithelial carcinoma
  • ovarian serous cystadenocarcinoma
  • ovarian endometrioid adenocarcinoma
  • ovarian clear cell cystadenocarcinoma
  • cervical squamous cell carcinoma
  • metastatic squamous neck cancer with occult primary squamous cell carcinoma
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • ovarian carcinosarcoma
  • Brenner tumor
  • untreated metastatic squamous neck cancer with occult primary
  • salivary gland squamous cell carcinoma
  • stage III salivary gland cancer
  • stage IV salivary gland cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • ovarian mucinous cystadenocarcinoma
  • stage IV pancreatic cancer
  • recurrent squamous cell carcinoma of the larynx
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)

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