DT388IL3 Fusion Protein in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes

• Status: Completed
• Trial end date: 2017-07-27
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Combinations of biological substances in DT388IL3 fusion protein may be able to carry cancer killing substances directly to the cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of DT388IL3 fusion protein and to see how well it works in treating patients with acute myeloid leukemia or myelodysplastic syndromes.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following:

• Histologically or morphologically confirmed acute myeloid leukemia (AML), meeting 1 of the following criteria:

• Relapsed or refractory AML after treatment with ≥ 1 prior conventional induction therapy

• Patients in early first relapse must not have a matched donor available and/or be ineligible for allogeneic stem cell transplantation

• Poor-risk AML, as defined by any of the following criteria:

• Treatment-related AML, unless associated with favorable cytogenetics (e.g., inversion 16, t[16;16], t[8;21], t[15;17]), and ineligible for stem cell transplantation

• Antecedent hematological disease (e.g., myelodysplastic syndromes, myelofibrosis, or polycythemia vera) that evolved to AML (≥ 20% blasts) and ineligible for stem cell transplantation

• De novo AML (must be > 70 years of age)

• AML with unfavorable cytogenetics (e.g., abnormalities of chromosomes -7, -5, 7q-, or 5q-; complex [≥ 3] abnormalities; or abnormalities of 11q23, excluding t[9;11], t[9;22], inversion 3, t[3;3], and t[6;9]), regardless of age, and ineligible for allogeneic stem cell transplantation

• High-risk myelodysplastic syndromes diagnosed by morphologic, histochemical, or cell surface marker criteria

• Resistant or intolerant to chemotherapy

• Ineligible for or unwilling to undergo immediate allogeneic stem cell transplantation

• Bone marrow index (i.e., percent cellularity × percent blasts) ≤ 40% at time of treatment

• No active CNS leukemia

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Bilirubin ≤ 1.5 mg/dL

• ALT and AST < 2.5 times upper limit of normal

• Albumin ≥ 3 mg/dL

• Creatinine ≤ 1.5 mg/dL

• LVEF ≥ 50%

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 2 weeks after completion of study treatment

• No complicated medical or psychiatric problems that would preclude study compliance

• No concurrent serious uncontrolled infection or disseminated intravascular coagulation

• No myocardial infarction within the past 6 months

• No allergies to diphtheria toxin

• No requirement for oxygen

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No other concurrent antineoplastic drugs

• No concurrent radiotherapy

• No concurrent corticosteroids as antiemetics

• No concurrent hematopoietic growth factors (e.g., epoetin alfa, interleukin-11, filgrastim [G-CSF], or sargramostim [GM-CSF])

• No concurrent intravenous immunoglobins