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
  Purpose

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.


Condition Intervention Phase
Leukemia
Drug: cyclosporine
Drug: gemtuzumab ozogamicin
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial Combining Gemtuzumab Ozogamicin (Mylotarg) With Cyclosporine for the Treatment of Relapsed Acute Myeloid Leukemia in Adults Over Age 60

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Efficacy in terms of complete remission rate [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlate clinical response to laboratory studies of drug susceptibility [ Designated as safety issue: No ]

Study Start Date: May 2004
Study Completion Date: March 2006
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00089050

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Stephen H. Petersdorf, MD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00089050     History of Changes
Other Study ID Numbers: 1820.00, FHCRC-1820.00, CDR0000378021
Study First Received: August 4, 2004
Last Updated: November 28, 2011
Health Authority: United States: Federal Government

Keywords provided by Fred Hutchinson Cancer Research Center:
recurrent adult acute myeloid leukemia
adult acute minimally differentiated myeloid leukemia (M0)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
adult acute monocytic leukemia (M5b)
adult erythroleukemia (M6a)
adult pure erythroid leukemia (M6b)
adult acute megakaryoblastic leukemia (M7)
adult acute basophilic leukemia
adult acute eosinophilic leukemia
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cyclosporins
Cyclosporine
Gemtuzumab
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 29, 2014