Clinical Trials /

Safety Study of CAT-8015 Immunoxin in Patients With NHL With Advance Disease

NCT00515892

Description:

RATIONALE: The CAT-8015 immunotoxin can bind tumor cells and kill them without harming normal cells. This may be effective treatment for Non-Hodgkin's lymphoma (NHL) that has not responded to chemotherapy, surgery or radiation therapy. PURPOSE: Phase 1 dose escalation study to determine the maximum tolerated dose of CAT-8015 immunotoxin in treating patients who have Non-Hodgkin's lymphoma and do not respond to treatment.

Related Conditions:
  • Non-Hodgkin Lymphoma
Recruiting Status:

Unknown status

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Safety Study of CAT-8015 Immunoxin in Patients With NHL With Advance Disease
  • Official Title: A Phase 1, Multicenter, Dose Escalation Study of CAT-8015 in Patients With Relapsed or Refractory Non-Hodgkin'd Lymphoma (NHL)

Clinical Trial IDs

  • ORG STUDY ID: CAT-8015-1003
  • NCT ID: NCT00515892
  • NCT ALIAS: NCT00522483

Conditions

  • Leukemia
  • Non-Hodgkin's Lymphoma
  • NHL

Interventions

DrugSynonymsArms
Immunotoxin therapy
CAT-8015 Immunotoxin

Purpose

RATIONALE: The CAT-8015 immunotoxin can bind tumor cells and kill them without harming normal cells. This may be effective treatment for Non-Hodgkin's lymphoma (NHL) that has not responded to chemotherapy, surgery or radiation therapy. PURPOSE: Phase 1 dose escalation study to determine the maximum tolerated dose of CAT-8015 immunotoxin in treating patients who have Non-Hodgkin's lymphoma and do not respond to treatment.

Trial Arms

NameTypeDescriptionInterventions

Eligibility Criteria

        INCLUSION CRITERIA:

        DISEASE CHARACTERISTICS:

          -  Confirmed diagnosis of B-cell non-Hodgkin's lymphoma

          -  Measurable disease

          -  Evidence of CD22-positive malignancy by the following criteria,

               -  > 30% of malignant cells from a disease site CD22+ by FACS analysis or,

               -  > 15% of malignant cells from a disease site must react with anti-CD22 by
                  immunohistochemistry

          -  Patients with indolent subtypes of CD22+ B-cell non-Hodgkin's lymphoma, including, but
             not limited to mantle cell lymphoma, follicular lymphoma and Waldenström's
             macroglobulinemia, are eligible if stage III-IV.

          -  Patients must have failed at least two or more courses of prior standard chemotherapy
             and/or biologic therapy (e.g. Rituxan). Patients with progressive mantle cell lymphoma
             may be eligible if they have failed one prior standard therapeutic regimen.

        PATIENTS CHARACTERISTICS

        Performance Status

          -  ECOG 0-2

        Life Expectancy

          -  Life expectancy of less than 6 months, as assessed by the principal investigator

        Other

          -  Patients with other cancers who meet eligibility criteria and have less than 5 years
             of disease free survival will be considered on a case-by-case basis

          -  Must be able to understand and sign informed consent

          -  Female and male patients must agree to use an approved method of contraception during
             the study

        Exclusion Criteria:

          -  History of bone marrow transplant

          -  Documented and ongoing central nervous system involvement with their malignant disease
             (history of CNS involvement is not an exclusion criterion)

          -  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).

          -  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

          -  Baseline coagulopathy > Grade 3 unless due to anticoagulant therapy.

        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: Patient with no prior history of pulmonary illness are not
             required to have PFTs. FEV1 will be assessed after bronchodilator therapy.

        Recent prior therapy:

          -  Cytotoxic chemotherapy, corticosteroids (except stable doses of prednisone), whole
             body electron beam radiation therapy, hormonal, biologic or other standard or any
             investigational therapy of the malignancy for 3 weeks prior to entry into the trial

          -  Less than or equal < 3 months prior monoclonal antibody therapy (i.e. rituximab)

          -  Patients who are receiving or have received 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 prior pseudomonas-exotoxin immunotoxin (PE) administration.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Estimate the maximum dose that can be safely administered to a patient; Characterize the toxicity profile of CAT-8015; Study the clinical pharmacology of CAT-8015; Observe anti-tumor activity, if any.
Time Frame:
Safety Issue:
Description:

Secondary Outcome Measures

Measure:To assess the immunogenic potential of CAT-8015 to induce antibodies; To investigate the potential of biomarkers to predict any therapeutic or toxic response.
Time Frame:
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Unknown status
Lead Sponsor:Cambridge Antibody Technology

Last Updated

August 14, 2007