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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00089050
First received: August 4, 2004
Last updated: November 28, 2011
Last verified: November 2011

August 4, 2004
November 28, 2011
May 2004
Not Provided
  • Efficacy in terms of complete remission rate [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00089050 on ClinicalTrials.gov Archive Site
Correlate clinical response to laboratory studies of drug susceptibility [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Gemtuzumab Ozogamicin and Cyclosporine in Treating Older Patients With Relapsed Acute Myeloid Leukemia
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.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Leukemia
  • Drug: cyclosporine
  • Drug: gemtuzumab ozogamicin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
March 2006
Not Provided

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
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00089050
1820.00, FHCRC-1820.00, CDR0000378021
Not Provided
Not Provided
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Principal Investigator: Stephen H. Petersdorf, MD Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP