Safety Study of CAT-8015 Immunooxin in Patients With HCL With Advance Disease

Phase 1

• Conditions: Leukemia; Hairy Cell Leukemia; HCL

• Registration Number: NCT00462189
• 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 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.

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.

Study Timeline

• Status Verified: 2007-04
• Study Start: 2007-04
• Study First Submitted: 2007-04-16
• Study First Submitted QC: 2007-04-16
• Last Update Submitted: 2007-04-16
• Study First Posted: 2007-04-18
• Last Update Posted: 2007-04-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

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
Characterize the toxicity profile of CAT-8015
Study the clinical pharmacology of CAT-8015
Observe anti-tumor activity, if any.

Secondary Outcome Measures

Name	Time	Method
To assess the immunogenic potential of CAT-8015 to induce antibodies
To investigate the potential of biomarkers to predict any therapeutic or toxic response.

Trial Locations

Locations (5)

Klinika Hamtologii Uniwersytetu Medycznego (Medical University of Lodz); 🇵🇱 Lodz, Poland

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States

Royal Marsden Hospital and Institute of Cancer Research; 🇬🇧 Surrey, United Kingdom

Cancer Center of Northwestern University; 🇺🇸 Chicago, Illinois, United States

Warren Grant Megnuson Clinical Center - NCI Clinical Trials Referral Office; 🇺🇸 Bethesda, Maryland, United States