Clinical trial NCT00904514: Study of Previously Collected and Stored Tissue Samples From Patients Previously Enrolled in a Completed National Cancer Institute 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
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
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)
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-19
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

Eligibility 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

Primary outcomes:
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
measure: Correlation of plasma levels and pharmacokinetics with disease burden and presence of antibodies
measure: Correlation of tumor markers with disease burden
measure: Utility of tumor markers for following patients after treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Cancer Institute (NCI)
name: Robert Kreitman, MD
role: PRINCIPAL_INVESTIGATOR
References: