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Phase I/II Study of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin for Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT00660036
Recruitment Status : Terminated (due to new safety information)
First Posted : April 17, 2008
Last Update Posted : January 15, 2016
Sponsor:
Information provided by (Responsible Party):
Michael Boyiadzis, University of Pittsburgh

Study Description
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Brief Summary:
The purpose of this study is to investigate the combination of gemtuzumab ozogamicin, mitoxantrone and etoposide as second line therapy in patients with acute myeloid leukemia.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Gemtuzumab ozogamicin Drug: Mitoxantrone Drug: Etoposide Phase 1

Detailed Description:
The combination of mitoxantrone and etoposide is an active regimen in refractory/relapsed AML patients. In order to improve the efficacy of mitoxantrone and etoposide as second line therapy in patients with AML we proposed to conduct a phase I/II clinical trial combining gemtuzumab ozogamicin with mitoxantrone and etoposide. The phase I portion of the trial will determine the maximum tolerated dose of gemtuzumab ozogamicin combined with mitoxantrone and etoposide and the phase II portion of the trial will determine the efficacy and safety of the combined regimen in patients with AML.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of the Combination of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin for Patients With Acute Myeloid Leukemia Refractory to Initial Standard Induction Therapy (UPCI 07-154)
Study Start Date : September 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Gemtuzumab ozogamicin/Mitoxantrone/Etoposide Drug: Gemtuzumab ozogamicin
On Day 6 of an inpatient hospital stay: Based on the study design patients will be treated with one of three doses (3 mg/m^2, 6 mg/m^2 or 9 mg/m^2), administered intravenously in 100 ml of 0.9% sodium chloride over 2 hours.
Other Name: Mylotarg®

Drug: Mitoxantrone
On Days 1-3 of an inpatient hospital stay: 10 mg/m^2 administered via IVPB (intravenous piggy-back) in 50ml normal saline (NS) over 15 minutes
Other Name: Novantrone®

Drug: Etoposide
On Days 1-5 of an inpatient hospital stay: 100 mg/m^2 administered intravenously in 500 ml of 0.9% sodium chloride over 2 hours
Other Name: ToposarTM


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the toxicity and response rate of the combination therapy of mitoxantrone, etoposide and gemtuzumab ozogamicin as second line therapy in patients with acute myeloid leukemia (AML). [ Time Frame: Bone marrow biopsy and aspiration 14 days after gemtuzumab ozogamicin administration, to evaluate response to the study drug regimen. ]

Secondary Outcome Measures :
  1. To assess the overall survival in patients with AML treated with the combination of mitoxantrone, etoposide and gemtuzumab ozogamicin. [ Time Frame: Indefinite; subjects are followed for survival. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to understand and have the ability to provide written consent
  • Between 18 and 70 years of age
  • Patients with CD33 positive (determined as CD33 expression in ≥ 20% of leukemic blasts) de novo AML that did not respond to first line induction therapy
  • ECOG Performance Status of 0-2
  • Patients must have the following laboratory values within 48 hours prior to beginning protocol treatment: Serum creatinine ≤ 1.5 mg/ml and calculated creatinine clearance ≥ 50mL/min (using the Cockcroft-Gault equation); AST ≤ 59 IU/L; ALT ≤ 72 IU/L; Total bilirubin ≤ 1.3 mg/ml; Note: Hematologic abnormalities will not be used as a criteria for entry or exclusion.
  • Patients must have left ventricular ejection fraction (LVEF) ≥50%
  • Females of child-bearing potential must have a negative pregnancy test during screening and all subjects must agree to use an effective method of contraception.

Exclusion Criteria:

  • Patients with acute promyelocytic leukemia
  • Prior use of mitoxantrone or etoposide or gemtuzumab ozogamicin
  • Antecedent hematologic disorder preceding initial presentation of AML or therapy related AML
  • History of thromboembolic event within the past 12 months
  • Hepatitis B or C or HIV positive serology
  • Symptomatic central nervous system (CNS) involvement
  • History of congestive heart failure
  • Myocardial infarction in the past 6 months
  • Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy
  • History of psychiatric disorder which may compromise compliance with the protocol or which does not allow for appropriate informed consent
  • Patient may not be receiving any other anti neoplastic investigational agents
  • INR> 1.5 or patient is receiving systemic anticoagulation (e.g warfarin)
  • Patient undergone autologous or allogeneic stem cell transplantation
  • Other active malignancies except for non-melanoma skin cancer or cervical intraepithelial neoplasia
  • Women who are pregnant or breastfeeding.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00660036


Locations
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United States, Pennsylvania
University of Pittsburgh Cancer Institute / Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Michael Boyiadzis, MD University of Pittsburgh
More Information
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Responsible Party: Michael Boyiadzis, PI, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00660036    
Other Study ID Numbers: 07-154
First Posted: April 17, 2008    Key Record Dates
Last Update Posted: January 15, 2016
Last Verified: January 2016
Keywords provided by Michael Boyiadzis, University of Pittsburgh:
Acute myeloid leukemia
Refractory
Relapsed
Second line
Gemtuzumab ozogamicin
 Mitoxantrone
Etoposide
Phase I
Phase II
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Etoposide
Mitoxantrone
Gemtuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
 Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antineoplastic Agents, Immunological