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

Information source: University of Pittsburgh
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Myeloid Leukemia

Intervention: Gemtuzumab ozogamicin (Drug); Mitoxantrone (Drug); Etoposide (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: University of Pittsburgh

Official(s) and/or principal investigator(s):
Michael Boyiadzis, MD, Principal Investigator, Affiliation: University of Pittsburgh

Overall contact:
Michael Boyiadzis, MD, Phone: 412-648-6589, Email: boyiadzism@upmc.edu

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.

Clinical Details

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 design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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).

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

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.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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.

Locations and Contacts

Michael Boyiadzis, MD, Phone: 412-648-6589, Email: boyiadzism@upmc.edu

University of Pittsburgh Cancer Institute / Hillman Cancer Center, Pittsburgh, Pennsylvania 15232, United States; Recruiting
Michael Boyiadzis, MD, Principal Investigator
Mounzer Agha, MD, Sub-Investigator
Anastasios Raptis, MD, Sub-Investigator
Suzanne Lentzsch, MD, PhD, Sub-Investigator
Markus Y. Mapara, MD, PhD, Sub-Investigator
David Roodman, MD, PhD, Sub-Investigator
Roy Smith, MD, Sub-Investigator
Ahmad A. Tarhini, MD, MSc, Sub-Investigator
Robert L. Redner, MD, Sub-Investigator
Jing-Zhou Hou, MD, Sub-Investigator
Additional Information

Starting date: September 2008
Last updated: April 28, 2011

Page last updated: August 23, 2015

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