Safety Study of CAT-8015 Immunotoxin in Patients With CLL, PLL or SLL With Advance Disease
- Conditions
- Leukemia
- Registration Number
- NCT00457860
- Lead Sponsor
- Cambridge Antibody Technology
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Estimate the maximum dose that can be safely administered to a patient Study the clinical pharmacology of CAT-8015 Observe anti-tumor activity, if any Characterize the toxicity profile of CAT-8015
- Secondary Outcome Measures
Name Time Method To Investigate the potential of biomarkers to predict any therapeutic or toxic response To assess the potential of CAT-8015 to induce antibodies
Trial Locations
- Locations (4)
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Tower Hematology Oncology Medical Group
🇺🇸Beverly Hills, California, United States
Warren Grant Megnuson Clinical Center - NCI Clinical Trials Referral Office
🇺🇸Bethesda, Maryland, United States
Klinika Hemtologii Uniwersytetu Medycznego (Medical University of Lodz)
🇵🇱Lodz, Poland