Gemtuzumab Ozogamicin and Cyclosporine in Treating Older Patients With Relapsed Acute Myeloid Leukemia

November 28, 2011 updated by: Fred Hutchinson Cancer Center

A Phase II Trial Combining Gemtuzumab Ozogamicin (Mylotarg) With Cyclosporine for the Treatment of Relapsed Acute Myeloid Leukemia in Adults Over Age 60

RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Cyclosporine may increase the effectiveness of gemtuzumab ozogamicin by making cancer cells more sensitive to the drug. Combining gemtuzumab ozogamicin with cyclosporine may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving gemtuzumab ozogamicin together with cyclosporine works in treating older patients with relapsed acute myeloid leukemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine the efficacy of gemtuzumab ozogamicin and cyclosporine, in terms of the complete remission rate, in older patients with relapsed acute myeloid leukemia.
  • Determine the toxicity and pharmacokinetics of this regimen in these patients.

Secondary

  • Correlate clinical response with laboratory studies of drug susceptibility in patients treated with this regimen.

OUTLINE: Patients receive cyclosporine IV continuously over 72 hours on days 1-3 and 15-17. Eight hours after initiation of each cyclosporine infusion, patients receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 3 years.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109-1024
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Morphologically confirmed acute myeloid leukemia (AML) by bone marrow aspirate

    • More than 20% blasts by morphologic criteria
    • Relapsed disease ≥ 3 months after prior complete remission
  • Blasts CD33-positive by flow cytometry
  • No primary hematologic disorder that preceded initial presentation with AML
  • No documented secondary AML related to prior chemotherapy or toxin exposure
  • No acute promyelocytic leukemia (FAB M3)
  • Not a candidate for transplant therapy
  • No active CNS leukemia

PATIENT CHARACTERISTICS:

Age

  • 60 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified

Hematopoietic

  • WBC ≤ 30,000/mm^3 (hydroxyurea allowed)

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST or ALT ≤ 1.5 times ULN

Renal

  • Creatinine ≤ 1.5 mg/dL

Other

  • HIV negative
  • No uncontrolled infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not planning hematopoietic stem cell transplantation immediately after study therapy

Chemotherapy

  • See Disease Characteristics
  • See Hematopoietic

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • More than 1 month since prior investigational agents
  • No other concurrent anticancer therapy

  • No administration of any of the following for 24 hours after cyclosporine administration:

    • Diltiazem
    • Verapamil
    • Erythromycin
    • Clarithromycin
    • Metoclopramide
    • Phenytoin
    • Rifampin
    • Phenobarbital
    • Aminoglycosides
    • Amphotericin B
    • Vancomycin
    • Cimetidine
    • Ranitidine
    • Trimethoprim/sulfamethoxazole
    • Ketoconazole
    • Fluconazole
    • Itraconazole
    • Voriconazole
    • Carbamazepine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Toxicity
Pharmacokinetics
Efficacy in terms of complete remission rate

Secondary Outcome Measures

Outcome Measure
Correlate clinical response to laboratory studies of drug susceptibility

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

August 4, 2004

First Submitted That Met QC Criteria

August 4, 2004

First Posted (Estimate)

August 5, 2004

Study Record Updates

Last Update Posted (Estimate)

November 30, 2011

Last Update Submitted That Met QC Criteria

November 28, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1820.00
  • FHCRC-1820.00
  • CDR0000378021 (Registry Identifier: PDQ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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