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Sponsored by: |
Cambridge Antibody Technology |
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Information provided by: | Cambridge Antibody Technology |
ClinicalTrials.gov Identifier: | NCT00457860 |
RATIONALE: The CAT-8015 immunotoxin can bind tumor cells and kill them without harming normal cells. This may be an effective treatment for chronic lymphocytic leukemia (CLL), prolymphocytic leukemia (PLL), or small lymphocytic lymphoma (SLL that has not responded to chemotherapy, surgery or radiation therapy.
PURPOSE: Phase I dose escalation study to determine the maximum tolerated dose of CAT-8015 immunotoxin in treating patients who have chronic lymphocytic leukemia, prolymphocytic leukemia or small lymphocytic lymphoma that has not responded to treatment
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: Immunotoxin therapy Drug: CAT-8015 immunotoxin Procedure: Biological therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study |
Official Title: | A Phase 1, Multicenter, Dose Escalation Study of CAT-8015 in Patients With Relapse or Refractory Chronic Lymphocytic Leukemia (CLL), Prolymphocytic Leukemia (PLL), or Small Lymphocytic Lymphoma (SLL) |
Estimated Enrollment: | 50 |
Study Start Date: | March 2007 |
OUTLINE: Patients receive CAT-8015 IV over 30 minutes on days 1, 3, and 5 followed by rest. Treatment repeats every 4 weeks for up to a total of 10 courses in the absence of dose limiting toxicity, complete response or disease progression. Patients are followed at 1, 3, 6,12,15,18, 21, 24 months following the start of the last treatment cycle.
Cohorts of 3-6 patients each will receive escalating doses of recombinant CAT-8015 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose proceeding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, between16 to 25 new patients will be added to the MTD cohort depending on how well the CAT-8015 is tolerated.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Other
EXCLUSION CRITERIA:
Hepatic function: serum transaminases (either ALT or AST) or direct bilirubin:
Renal function: serum creatinine clearance ≤60mL/min as estimated by Cockroft-Gault formula
Hematologic function:
Pulmonary function:
Recent prior therapy:
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, Indiana | |
Indiana University Cancer Center | Not yet recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Mary Cangany, RN, CCRP 317-278-4694 | |
Principal Investigator: Larry Cripe, 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 Hemtologii Uniwersytetu Medycznego (Medical University of Lodz) | Not yet recruiting |
Lodz, Poland | |
Contact: Krzysztof Jamoziak, MD 00 48 42 689 5191 | |
Principal Investigator: Tadeusz Robak, Professor |
Study ID Numbers: | CAT-8015-1002 |
Study First Received: | April 5, 2007 |
Last Updated: | April 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00457860 |
Health Authority: | United States: Food and Drug Administration |
CLL PLL SLL Relapse Refractory |
immunotoxin HA22 CAT-8015 immunotherapy |
Chronic lymphocytic leukemia Leukemia, Lymphoid Immunoproliferative Disorders Leukemia, B-cell, chronic Immunotoxins Leukemia Lymphatic Diseases |
Leukemia, Prolymphocytic Leukemia, Lymphocytic, Chronic, B-Cell Prolymphocytic leukemia Leukemia, B-Cell Lymphoproliferative Disorders Lymphoma |
Neoplasms Neoplasms by Histologic Type Immunologic Factors |
Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |