Safety Study of CAT-8015 Immunoxin in Patients With NHL With Advance Disease
NHL
A Phase 1, Multicenter, Dose Escalation Study of CAT-8015 in Patients With Relapsed or Refractory Non-Hodgkin'd Lymphoma (NHL)
1 other identifier
interventional
50
2 countries
3
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 leukemia
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 10, 2007
CompletedFirst Posted
Study publicly available on registry
August 14, 2007
CompletedAugust 14, 2007
August 1, 2007
August 10, 2007
August 10, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To assess the immunogenic potential of CAT-8015 to induce antibodies; To investigate the potential of biomarkers to predict any therapeutic or toxic response.
Interventions
Eligibility Criteria
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
- +2 more criteria
You may not qualify if:
- History of bone marrow transplant
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Tower Hematology Oncology Medical Group
Beverly Hills, California, 90211, United States
Warren Grant Megnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, 20892, United States
Klinika Hamtologii Uniwersytetu Medycznego (Medical University of Lodz)
Lodz, Poland
Related Publications (1)
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.
PMID: 16061911BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 10, 2007
First Posted
August 14, 2007
Study Start
August 1, 2007
Last Updated
August 14, 2007
Record last verified: 2007-08