A Phase 1, Multicenter, Dose Escalation Study of CAT-8015 in Patients With Relapsed or Refractory Non-Hodgkin'd Lymphoma (NHL)
| Registry | NCT00515892, acronym NHL |
|---|---|
| Status | Unknown |
| Phase | Phase 1 |
| Study type | Interventional; non randomized, single group, masking: none, treatment |
| Enrollment | 50 (Estimated) |
| Sponsor | Cambridge Antibody Technology (Other) |
| Conditions | Leukemia, Non-Hodgkin's Lymphoma, NHL |
| Interventions | Immunotoxin therapy, CAT-8015 Immunotoxin, Biological therapy, Antibody Therapy, Monoclonal Antibody Therapy (Drug, procedure) |
| Dates | start 2007-08-01, first posted 2007-08-14, last updated 2007-08-14 |
| Locations | 3 sites in United States, Poland |
Related Papers Related Patents Related Grants Related Experts
All trials for Leukemia All trials for Non-Hodgkin's Lymphoma All trials of Immunotoxin therapy All trials of CAT-8015 Immunotoxin
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.
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Tower Hematology Oncology Medical Group | Beverly Hills, California | United States | Recruiting |
| Warren Grant Megnuson Clinical Center - NCI Clinical Trials Referral Office | Bethesda, Maryland | United States | Recruiting |
| Klinika Hamtologii Uniwersytetu Medycznego (Medical University of Lodz) | Lodz | Poland | Not yet recruiting |