Safety Study of CAT-8015 Immunoxin in Patients With NHL With Advance Disease
NCT ID: NCT00515892
Last Updated: 2007-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
50 participants
INTERVENTIONAL
2007-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Immunotoxin therapy
CAT-8015 Immunotoxin
Biological therapy
Antibody Therapy
Monoclonal Antibody Therapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Cambridge Antibody Technology
OTHER
Locations
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Tower Hematology Oncology Medical Group
Beverly Hills, California, United States
Warren Grant Megnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States
Klinika Hamtologii Uniwersytetu Medycznego (Medical University of Lodz)
Lodz, , Poland
Countries
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Facility Contacts
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Marie Fuerst, RN, MS
Role: primary
NCI Clinical Trials Referral Office
Role: primary
Krzysztof Jamroziak, MD
Role: primary
References
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Kreitman RJ, Squires DR, Stetler-Stevenson M, Noel P, FitzGerald DJ, Wilson WH, Pastan I. Phase I trial of recombinant immunotoxin RFB4(dsFv)-PE38 (BL22) in patients with B-cell malignancies. J Clin Oncol. 2005 Sep 20;23(27):6719-29. doi: 10.1200/JCO.2005.11.437. Epub 2005 Aug 1.
Other Identifiers
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CAT-8015-1003
Identifier Type: -
Identifier Source: org_study_id
NCT00522483
Identifier Type: -
Identifier Source: nct_alias