Safety Study of CAT-8015 Immunooxin in Patients With HCL With Advance Disease
Recruitment status was: Recruiting
RATIONALE: The CAT-8015 immunotoxin can bind tumor cells and kill them without harming normal cells. This may be an effective treatment for hairy cell leukemia(HCL) 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 hairy cell leukemia (HCL) that has not responded to treatment.
Hairy Cell Leukemia
Drug: Immunotoxin therapy
Drug: CAT-8015 Immunotoxin
Procedure: Biological therapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1, Multicenter, Dose Escalation Study of CAT-8015 in Patient With Relapsed or Refractory Hairy Cell Leukemia (HCL)|
- 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.
- To assess the immunogenic potential of CAT-8015 to induce antibodies
- To investigate the potential of biomarkers to predict any therapeutic or toxic response.
|Study Start Date:||April 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00462189
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|United States, Illinois|
|Cancer Center of Northwestern University|
|Chicago, Illinois, United States, 60611|
|United States, Maryland|
|Warren Grant Megnuson Clinical Center – NCI Clinical Trials Referral Office|
|Bethesda, Maryland, United States, 20892|
|Klinika Hamtologii Uniwersytetu Medycznego (Medical University of Lodz)|
|Royal Marsden Hospital and Institute of Cancer Research|
|Surrey, United Kingdom|