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Safety Study of CAT-8015 Immunoxin in Patients With NHL With Advance Disease
This study is currently recruiting participants.
Verified by Cambridge Antibody Technology, August 2007
Sponsored by: Cambridge Antibody Technology
Information provided by: Cambridge Antibody Technology
ClinicalTrials.gov Identifier: NCT00515892
  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.


Condition Intervention Phase
Leukemia
Non-Hodgkin's Lymphoma
NHL
Drug: Immunotoxin therapy
Drug: CAT-8015 Immunotoxin
Procedure: Biological therapy
Procedure: Antibody Therapy
Procedure: Monoclonal Antibody Therapy
Phase I

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma
Drug Information available for: Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title: A Phase 1, Multicenter, Dose Escalation Study of CAT-8015 in Patients With Relapsed or Refractory Non-Hodgkin'd Lymphoma (NHL)

Further study details as provided by Cambridge Antibody Technology:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • To assess the immunogenic potential of CAT-8015 to induce antibodies; To investigate the potential of biomarkers to predict any therapeutic or toxic response.

Estimated Enrollment: 50
Study Start Date: August 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00515892

Locations
United States, California
Tower Hematology Oncology Medical Group Recruiting
Beverly Hills, California, United States, 90211
Contact: Marie Fuerst, RN, MS     310-285-7269        
Principal Investigator: Peter Rosen, MD            
United States, Maryland
Warren Grant Megnuson Clinical Center - NCI Clinical Trials Referral Office Recruiting
Bethesda, Maryland, United States, 20892
Contact: NCI Clinical Trials Referral Office     888-624-1937        
Principal Investigator: Robert J Kreitman, MD            
Poland
Klinika Hamtologii Uniwersytetu Medycznego (Medical University of Lodz) Not yet recruiting
Lodz, Poland
Contact: Krzysztof Jamroziak, MD     (48) 42 689-5191        
Principal Investigator: Tadeusz Robak, Professor            
Sponsors and Collaborators
Cambridge Antibody Technology
  More Information

Publications:
Study ID Numbers: CAT-8015-1003
Study First Received: August 10, 2007
Last Updated: August 10, 2007
ClinicalTrials.gov Identifier: NCT00515892  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Antibodies, Monoclonal
Lymphatic Diseases
Leukemia
Antibodies
Immunoproliferative Disorders
Lymphoma, small cleaved-cell, diffuse
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Immunotoxins
Immunoglobulins

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009