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

Status unconfirmed · Phase 1

Conditions studied: Leukemia, Non-Hodgkin's Lymphoma, NHL

In brief

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.

Key facts

Study ID

NCT00515892

Run by

Cambridge Antibody Technology

People needed

50

Starts

2007-08-01

Last updated by the study team

2007-08-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Tower Hematology Oncology Medical Group — Beverly Hills, California, United States (enrolling)
• Warren Grant Megnuson Clinical Center - NCI Clinical Trials Referral Office — Bethesda, Maryland, United States (enrolling)
• Klinika Hamtologii Uniwersytetu Medycznego (Medical University of Lodz) — Lodz, Poland

Full record on ClinicalTrials.gov

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