DTGM Fusion Protein in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia

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. Identifier: NCT00003840
Recruitment Status : Completed
First Posted : April 12, 2004
Last Update Posted : January 19, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Leukemia Biological: DTGM fusion protein Phase 1 Phase 2

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 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.

Study Type : Interventional  (Clinical Trial)
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
Actual Primary Completion Date : September 2002
Actual Study Completion Date : July 2005

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically, morphologically, or cell surface marker confirmed adult acute myeloid leukemia (AML) Recurrent or refractory after at least 1 prior induction therapy OR Relapsed after remission of less than 1 year duration Antecedent myelodysplasia that has evolved to AML allowed Ineligible for allogeneic stem cell transplantation or failed prior transplantation No CNS leukemia

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC no greater than 10,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases less than 5 times upper limit of normal Albumin at least 3 g/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: Cardiac ejection fraction at least 50% normal No myocardial infarction within the past 6 months No disseminated intravascular coagulation Pulmonary: FEV1 at least 70% normal Other: No uncontrolled infections No other concurrent serious medical problems or psychiatric disorders No prior severe penicillin allergy (hives or anaphylactic reactions) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No concurrent growth factors Chemotherapy: See Disease Characteristics Recovered from prior chemotherapy Prior hydroxyurea or low-dose cytarabine (less than 100 mg subcutaneously) to lower blast counts allowed if discontinued on day 1 of study therapy No concurrent antineoplastic chemotherapy Endocrine therapy: Concurrent corticosteroids allowed, including antiemetics Radiotherapy: Recovered from prior radiotherapy No concurrent radiotherapy Surgery: Not specified

Information from the National Library of Medicine

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 identifier (NCT number): NCT00003840

United States, North Carolina
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157-1082
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Study Chair: Arthur E. Frankel, MD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences Identifier: NCT00003840     History of Changes
Other Study ID Numbers: CCCWFU-22300
CDR0000066998 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: April 12, 2004    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: June 2013

Keywords provided by Wake Forest University Health Sciences:
recurrent adult acute myeloid leukemia
secondary acute myeloid leukemia

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type