A Phase I, Multicenter, Dose Escalation Study of CAT-8015 in Patients With Non-Hodgkin's Lymphoma (NHL)
This study has been terminated.
(Due to a lack of IP supply and then terminated because they were combined into one new study with the new IP formulation.)
Information provided by (Responsible Party):
First received: December 21, 2007
Last updated: November 21, 2011
Last verified: November 2011
A dose-escalation study to estimate the maximum tolerated dose(MTD) of CAT-8015 that can be safely administered to a patient.
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase I, Multicenter, Dose Escalation Study of CAT-8015 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)
Primary Outcome Measures:
- Assess safety, estimate MTD, characterize toxicity profile, study pharmacology and observe anti-tumor activity at the MTD. [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Assess immunogenicity of CAT 8015 and potential biomarkers for therapeutic or toxicity responses. [ Time Frame: Day 0-7; 0-14 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2008 (Final data collection date for primary outcome measure)
Active Comparator: 1
The dose level of the initial cohort will be 5 μg/kg so cohorts will be dosed at 5, 10, 20, 30, 40, 50, 60…μg/kg until toxicity supervenes.
To estimate the maximum tolerated dose (MTD), defined as the highest dose that can be safely administered to a patient, and to establish a safe dose, based on MTD, for subsequent clinical testing.
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Subjects must meet all of the following criteria to be eligible to participate in the study:
- 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
- Disease characteristics: 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. 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.
- ECOG performance status of 0-2
- 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
- Life expectancy of less than 6 months, as assessed by the principal investigator
- Must be able to understand and sign informed consent
- Must be at least 18 years old
- Female and male patients must agree to use an approved method of contraception during the study
Subjects meeting any of the following criteria are not eligible for participation in the study:
- History of allogeneic 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
- 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
- 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.
Hepatic function Serum transaminases (either ALT or AST) or bilirubin:
- ≥ Grade 2, unless bilirubin is due to Gilbert's disease
- serum creatinine clearance ≤ 60mL/min as estimated by Cockroft-Gault formula
- 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 greater than or equal to Grade 3 unless due to anticoagulant therapy.
- 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: Patients 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 to 1 month 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00587015
|Tower Hematology Oncology Medical Group
|Beverly Hills, California, United States, 90211-1850 |
|NCI, National Institutes of Health
|Bethesda, Maryland, United States, 20892 |
|Kalinika Hemotologii Uniwersytetu Medycznego
|Lodz, Poland, 93-510 |
||Robert Leechleider, M.D.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 21, 2007
||November 21, 2011
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 23, 2014
Immune System Diseases
Neoplasms by Histologic Type