DTGM Fusion Protein in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia
RATIONALE: DTGM fusion protein may be able to locate cancer cells and stop them from growing.
PURPOSE: Phase I/II trial to study the effectiveness of DTGM fusion protein in treating patients who have recurrent or refractory acute myeloid leukemia.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study of DTGM Fusion Protein (IND BB#8153) in Relapsed and Refractory Adult Acute Myeloid Leukemia (AML)|
|Study Start Date:||October 2000|
|Study Completion Date:||July 2005|
|Primary Completion Date:||September 2002 (Final data collection date for primary outcome measure)|
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 mg/L or less vs greater than 2 mg/L). 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003840
|United States, North Carolina|
|Comprehensive Cancer Center of Wake Forest University Baptist Medical Center|
|Winston-Salem, North Carolina, United States, 27157-1082|
|Study Chair:||Arthur E. Frankel, MD||Wake Forest University Health Sciences|