Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462189
Status:
UNKNOWN
Last Update Posted:
2007-04-18
First Post:
2007-04-16
Brief Title:
Safety Study of CAT-8015 Immunooxin in Patients With HCL With Advance Disease
Sponsor:
Cambridge Antibody Technology
Organization:
Cambridge Antibody Technology
Study Overview
Official Title:
A Phase 1 Multicenter Dose Escalation Study of CAT-8015 in Patient With Relapsed or Refractory Hairy Cell Leukemia HCL
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 leukemiaHCL 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
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 6121518 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None