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Collection of Human Samples to Study Hairy Cell and Other Leukemias and to Develop Recombinant Immunotoxins for Cancer Treatment


N/A
18 Years
N/A
Open (Enrolling)
Both
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL), Non-Hodgkins Lymphoma (NHL), Cutaneous T Cell Lymphoma (CTCL), Adult T Cell Lymphoma (ATL)

Thank you

Trial Information

Collection of Human Samples to Study Hairy Cell and Other Leukemias and to Develop Recombinant Immunotoxins for Cancer Treatment


Background:

- Hairy cell leukemia (HCL) is highly responsive to but not curable by standard
chemotherapy, and also responds well to investigational agents called recombinant
immunotoxins which are being developed by the Laboratory of Molecular Biology (LMB).

- The investigators on this protocol are studying molecular and clinical aspects of HCL,
and how they compare to normal or to other disorders, including chronic lymphocytic
leukemia (CLL) non-Hodgkin's lymphoma (NHL), and acute lymphoblastic leukemia (ALL).

- Recombinant immunotoxins are fusion proteins containing a bacterial toxin connected to
a targeting ligand, like a single-chain antibody or a growth factor. Recombinant
immunotoxins currently under clinical development in the LMB include BL22 and a high
affinity variant, HA22, targeting CD22, LMB-2, targeting CD25, and SS1P, targeting
Mesothelin.

- LMB-2, BL22 and HA22 are being tested in purine analog resistant HCL.

- Other LMB trials include LMB-2 for cutaneous T-cell lymphoma, chronic lymphocytic
leukemia (CLL), and adult T-cell leukemia, and HA22 for non-Hodgkin's lymphoma and CLL.

Objectives:

- Primary: To allow the collection of a variety of clinical samples, including blood, urine,
lymphopheresis samples, and other tissues, in order to improve the efficacy and safety of
recombinant immunotoxins, to better understand the disease processes which are being
treated, and to determine eligibility and optimal timing for clinical testing. Specific
projects planned include 1) studying antibodies made against immunotoxins, 2) quantifying
tumor antigens by flow cytometry, 3) testing how well recombinant immunotoxins kill tumor
cells ex vivo, 4) quantifying soluble antigens like CD22 and CD25 in the serum of patients
and normal controls, 5) molecularly characterizing malignant B-cells by sequencing their
immunoglobulin rearrangements.

Eligibility:

- Samples which are easily obtained, including blood and urine, may be obtained from
patients and normal volunteers.

- Samples requiring procedures, including bone marrow biopsy/aspiration, leukopheresis,
and any procedure done because of medical need, may be obtained from patients.

Design:

- Patients or normal donors are consented for the protocol and samples are obtained.

- This protocol does not involve treatment, although patients may also be on therapy or
protocol treatment.

Inclusion Criteria


- INCLUSION CRITERIA:

1. Patients may have a diagnosis of hematologic malignancy, including HCL, CLL,
CTCL, ATL, NHL, ALL, or solid tumor, including mesothelioma. These patients
would not be excluded if they were in complete remission or thought to be cured
of their malignancy.

2. Patients and normal volunteer donors must be at least 18 years of age.

3. Ability to give informed consent.

4. Samples which are easily obtained, including blood and urine, may be obtained
from patients and normal volunteers.

5. Samples requiring procedures, including bone marrow biopsy/aspiration,
leukopheresis, lymph node or tumor aspirate or biopsy, and any procedure done
because of medical need, may be obtained from patients.

6. For patients undergoing leukopheresis for research purposes, the hematocrit must
be at least 28% and the platelet count at least 50,000/mm(3).

7. Inclusion of Women and Minorities-Both men and women and members of all races
and ethnic groups are eligible for this trial.

EXCLUSION CRITERIA:

Desire of the patient or normal donor not to submit samples.

Exclusion Criteria for normal donors:

- Heart, lung, kidney disease, or bleeding disorders.

- Diagnosis of cancer

- Hepatitis since age 11.

- Pregnancy

- History of HIV infection or AIDS

- History of high-risk activities for exposure to the AIDS virus, including:

- Receipt of money or drugs in exchange for sex in the past 5 years.

- Use of needles to take drugs, steroids, or anything not prescribed by a
physician in the past 5 years

- Sexual contact in past 12 months with anyone having these high-risk activities
or anyone whose status is unknown.

- Symptoms of AIDS or other infection in past 12 months including:

- Unexplained weight loss or night sweats

- Blue or purple spots in the mouth or skin

- White spots or unusual sores in the mouth

- Persistent cough or shortness of breath

- Chronic diarrhea

- Fever of more than 100.5 degrees F for more than 10 days

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Robert J Kreitman, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

100066

NCT ID:

NCT01087333

Start Date:

February 2010

Completion Date:

Related Keywords:

  • Hairy Cell Leukemia (HCL)
  • Chronic Lymphocytic Leukemia (CLL)
  • Non-Hodgkins Lymphoma (NHL)
  • Cutaneous T Cell Lymphoma (CTCL)
  • Adult T Cell Lymphoma (ATL)
  • Cytotoxicity Assay
  • Neutralizing Antibodies
  • Apheresis
  • Flow Cytometry
  • Hemolytic Uremic Syndrome (HUS)
  • Leukemia
  • Lymphoma
  • Hairy Cell Leukemia
  • Chronic Lymphocytic Leukemia
  • Non-Hodgkin Lymphoma
  • Cutaneous T Cell Lymphoma
  • Adult T Cell Lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Hairy Cell
  • Leukemia, Lymphoid
  • Leukemia-Lymphoma, Adult T-Cell
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892