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Status:

UNKNOWN

Safety Study of CAT-8015 Immunooxin in Patients With HCL With Advance Disease

Lead Sponsor:

Cambridge Antibody Technology

Conditions:

Leukemia

Hairy Cell Leukemia

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

RATIONALE: The CAT-8015 immunotoxin can bind tumor cells and kill them without harming normal cells. This may be an effective treatment for hairy cell leukemia(HCL) that has not responded to chemother...

Detailed Description

OUTLINE: Patients receive CAT-8015 IV over 30 minutes on days 1, 3, and 5 followed by rest. Treatment repeats every 4 weeks for up to a total of 10 courses in the absence of dose limiting toxicity, co...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • DISEASE CHARACTERISTICS:
  • Confirmed diagnosis of hairy cell leukemia
  • Measurable disease
  • At least one of the following indications for treatment:
  • Neutropenia (ANC \<1000 cells/µL)
  • Anemia (Hgb \<10g/dL)
  • Thrombocytopenia (Plt \<100,000/µL)
  • An absolute lymphocyte count of \>20,000 cells/µL, or
  • Symptomatic splenomegaly
  • Patient's must have had at least 2 prior systemic therapies. There must have been at least 2 prior courses of purine analog, or 1 if the response to this course lasted \<2 years, or if the patient had unacceptable toxicity to purine analog.
  • PATIENT CHARACTERISTICS:
  • Performance status • ECOG 0-2
  • Life expectancy
  • • Life expectancy of greater than 6 months, as assessed by the principal investigator
  • Other
  • Patients with other cancers who meet eligibility criteria and have had less than 5 years of disease free survival will be considered on a case-by-case basis
  • Ability to understand and sign informed consent
  • Female and male patients agree to use an approved method of contraception during the study
  • EXCLUSION CRITERIA:
  • Documented and ongoing central nervous system involvement with their malignant disease (history of CNS involvement is not an exclusion criterion)
  • History of bone marrow transplant
  • Pregnant or breast-feeding females
  • Patients whose plasma contains either a significant level of antibody to CAT-8015 as measured by ELISA, or antibody that neutralizes the binding of CAT-8015 to CD22 as measured by a competition ELISA.
  • HIV positive serology (due to increased risk of severe infection and unknown interaction of CAT-8015 with antiretroviral drugs)
  • Hepatitis B surface antigen positive
  • Uncontrolled, symptomatic, intercurrent illness including but not limited to: infections requiring systemic antibiotics, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements
  • Hepatic function: serum transaminases (either ALT or AST) or bilirubin:
  • • ≥ Grade 2, unless bilirubin is due to Gilbert's disease
  • Renal function: serum creatinine clearance ≤60mL/min as estimated by Cockroft-Gault formula
  • Hematologic function:
  • The ANC \<1000/cmm, or platelet count \<50,000/cmm, if these cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy)
  • Baseline coagulopathy \> grade 3 unless due to anticoagulant therapy
  • A patient will not be excluded because of pancytopenia ≥ Grade 3, or erythropoietin dependence, if it is due to disease, based on the results of bone marrow studies
  • Pulmonary function:
  • • Patients with \< 50% of predicted forced expiratory volume (FEV1) or \<50% of predicted diffusing capacity for carbon monoxide (DLCO), corrected for hemoglobin concentration and alveolar volume. Note: Patients with no prior history of pulmonary illness are not required to have PFTs. FEV1 will be assessed following bronchodilator therapy.
  • Recent prior therapy:
  • Cytotoxic chemotherapy (except stable doses of prednisone), whole body electron beam radiation therapy, interferon, retinoids or other systemic therapy, or investigational therapy of the malignancy for 3 weeks prior to entry into the trial
  • Less than or equal to \< 3 months prior monoclonal antibody therapy (i.e. rituximab)
  • Patients who have received or are receiving radiation therapy less than 3 weeks prior to study entry will be not be excluded providing the volume of bone marrow treated is less than 10% and also the patient has measurable disease outside the radiation port
  • Any history of pseudomonas-exotoxin (PE) immunotoxin administration

Exclusion

    Key Trial Info

    Start Date :

    April 1 2007

    Trial Type :

    INTERVENTIONAL

    End Date :

    Estimated Enrollment :

    40 Patients enrolled

    Trial Details

    Trial ID

    NCT00462189

    Start Date

    April 1 2007

    Last Update

    April 18 2007

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    Stanford University School of Medicine

    Stanford, California, United States, 94305

    2

    Cancer Center of Northwestern University

    Chicago, Illinois, United States, 60611

    3

    Warren Grant Megnuson Clinical Center - NCI Clinical Trials Referral Office

    Bethesda, Maryland, United States, 20892

    4

    Klinika Hamtologii Uniwersytetu Medycznego (Medical University of Lodz)

    Lodz, Poland