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

NCT00660036 | Terminated Phase 1 DMC

• 1 other identifier: 07-154
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Keywords

Acute myeloid leukemia; Refractory; Relapsed; Second line; Gemtuzumab ozogamicin; Mitoxantrone; Etoposide; Phase I; Phase II

Outcome Measures

Primary Outcomes (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).

  Bone marrow biopsy and aspiration 14 days after gemtuzumab ozogamicin administration, to evaluate response to the study drug regimen.

Secondary Outcomes (1)

• To assess the overall survival in patients with AML treated with the combination of mitoxantrone, etoposide and gemtuzumab ozogamicin.

  Indefinite; subjects are followed for survival.

Study Arms (1)

Gemtuzumab ozogamicin/Mitoxantrone/Etoposide

EXPERIMENTAL

Drug: Gemtuzumab ozogamicin; Drug: Mitoxantrone; Drug: Etoposide

Interventions

Gemtuzumab ozogamicin DRUG

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.

Also known as: Mylotarg®

Gemtuzumab ozogamicin/Mitoxantrone/Etoposide

Mitoxantrone DRUG

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

Also known as: Novantrone®

Gemtuzumab ozogamicin/Mitoxantrone/Etoposide

Etoposide DRUG

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

Also known as: ToposarTM

Gemtuzumab ozogamicin/Mitoxantrone/Etoposide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Cancer Institute / Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Recurrence

Interventions

Gemtuzumab; Mitoxantrone; Etoposide

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Calicheamicins; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Polycyclic Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides

Study Officials

• Michael Boyiadzis, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: April 11, 2008
• First Posted: April 17, 2008
• Study Start: September 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: January 15, 2016

Record last verified: 2016-01

Locations

US (1)