Safety Study of CAT-8015 Immunooxin in Patients With HCL With Advance Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00462189|
Recruitment Status : Unknown
Verified April 2007 by Cambridge Antibody Technology.
Recruitment status was: Recruiting
First Posted : April 18, 2007
Last Update Posted : April 18, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Hairy Cell Leukemia HCL||Drug: Immunotoxin therapy Drug: CAT-8015 Immunotoxin Procedure: Biological therapy||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Multicenter, Dose Escalation Study of CAT-8015 in Patient With Relapsed or Refractory Hairy Cell Leukemia (HCL)|
|Study Start Date :||April 2007|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00462189
|United States, California|
|Stanford University School of Medicine||Not yet recruiting|
|Stanford, California, United States, 94305|
|Contact: Sylvia Quesada, RN 650-725-4041|
|Principal Investigator: Steven E Coutre, MD|
|United States, Illinois|
|Cancer Center of Northwestern University||Not yet recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Simbi Acharya 312-695-1383|
|Principal Investigator: Martin Tallman, 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 888-624-1937|
|Principal Investigator: Robert J Kreitman, MD|
|Klinika Hamtologii Uniwersytetu Medycznego (Medical University of Lodz)||Not yet recruiting|
|Contact: Krzysztof Jamroziak, MD (48) 42 689-5191|
|Principal Investigator: Tadeusz Robak, Professor|
|Royal Marsden Hospital and Institute of Cancer Research||Not yet recruiting|
|Surrey, United Kingdom|
|Contact: Claire Dearden, MD (44) 20 7352 8171|
|Principal Investigator: Claire Dearden, MD|