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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Cambridge Antibody Technology.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Cambridge Antibody Technology
ClinicalTrials.gov Identifier:
NCT00515892
First received: August 10, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Dose Escalation Study of CAT-8015 in Patients With Relapsed or Refractory Non-Hodgkin'd Lymphoma (NHL)

Resource links provided by NLM:


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:
ClinicalTrials.gov Identifier: NCT00515892     History of Changes
Obsolete Identifiers: NCT00522483
Other Study ID Numbers: CAT-8015-1003
Study First Received: August 10, 2007
Last Updated: August 10, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunotoxins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014