Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003840
Status:
COMPLETED
Last Update Posted:
2017-01-19
First Post:
1999-11-01
Brief Title:
DTGM Fusion Protein in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
A Phase I Study of DTGM Fusion Protein IND BB8153 in Relapsed and Refractory Adult Acute Myeloid Leukemia AML
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE DTGM fusion protein may be able to locate cancer cells and stop them from growing
PURPOSE Phase III trial to study the effectiveness of DTGM fusion protein in treating patients who have recurrent or refractory acute myeloid leukemia
PURPOSE Phase III trial to study the effectiveness of DTGM fusion protein in treating patients who have recurrent or refractory acute myeloid leukemia
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of DTGM fusion protein in patients with recurrent or refractory adult acute myeloid leukemia II Determine the dose-limiting toxic effects of this regimen in these patients III Measure the pharmacokinetics of this regimen in these patients IV Evaluate the response rate at the maximum tolerated dose and immune responses in patients treated with this regimen V Correlate in vitro sensitivity of leukemic blasts to this regimen with the response rate in these patients VI Correlate tumor necrosis factor genetic polymorphisms with toxicity profiles and dose-limiting toxic effects of this regimen in these patients
OUTLINE This is a dose-escalation study Patients are stratified according to serum level of anti-DTGM antibody titer 2 mgL or less vs greater than 2 mgL Patients receive DTGM fusion protein IV over 15 minutes on days 1-5 Patients with a partial response are eligible for retreatment Cohorts of 3-6 patients receive escalating doses of DTGM fusion protein until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are accrued to receive treatment with DTGM fusion protein at the MTD Patients are followed monthly until disease progression
PROJECTED ACCRUAL Approximately 60 patients will be accrued for this study within 3 years
OUTLINE This is a dose-escalation study Patients are stratified according to serum level of anti-DTGM antibody titer 2 mgL or less vs greater than 2 mgL Patients receive DTGM fusion protein IV over 15 minutes on days 1-5 Patients with a partial response are eligible for retreatment Cohorts of 3-6 patients receive escalating doses of DTGM fusion protein until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are accrued to receive treatment with DTGM fusion protein at the MTD Patients are followed monthly until disease progression
PROJECTED ACCRUAL Approximately 60 patients will be accrued for this study within 3 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-H99-0027 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066998 | REGISTRY | None | None |
| CCCWFU-22198 | None | None | None |