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S0117 Gemtuzumab Ozogamicin Plus Cytarabine in Treating Patients With Relapsed Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00049179
First received: November 12, 2002
Last updated: January 12, 2012
Last verified: January 2012
History of Changes
  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. Drugs used in chemotherapy such as cytarabine use different ways to stop cancer cells from dividing so they stop growing or die. Combining gemtuzumab ozogamicin with cytarabine may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemtuzumab ozogamicin with cytarabine in treating patients who have relapsed acute myeloid leukemia.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Gemtuzumab Ozogamicin (Mylotarg) and Standard Dose ARA-C for Patients With Relapsed Acute Myeloid Leukemia (AML)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • CR [ Time Frame: After induction therapy is completed ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: April 2003
Study Completion Date: October 2010
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: cytarabine
    ind and consol: 200 mg/m2/d continuous IV days 1-7
    Drug: gemtuzumab ozogamicin
    ind and consol: 6 mg/m2 IV over 2 hrs day 1, 4mg/m2 IV over 2 hrs day 8
Detailed Description:

OBJECTIVES:

  • Determine the safety and efficacy of gemtuzumab ozogamicin and cytarabine in patients with relapsed acute myeloid leukemia.
  • Determine the frequency and severity of toxic effects of this regimen in CD33-positive patients.
  • Determine, preliminarily, the prognostic significance of drug resistance phenotype, cytogenetics, and molecular genetic characteristics of patients treated with this regimen.

OUTLINE: This is a multicenter study.

  • Induction: Patients receive gemtuzumab ozogamicin IV over at least 2 hours on days 1 and 8 and cytarabine IV continuously over days 1-7.
  • Consolidation: Beginning between days 28 and 75, patients who achieve A1 bone marrow, B1 peripheral blood, and C1 extramedullary disease status receive one course of gemtuzumab ozogamicin and cisplatin as in induction chemotherapy.

Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 30-55 patients will be accrued for this study within 10-28 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed acute myeloid leukemia (AML)

    • FAB M1-2 or M4-7
    • No blastic transformation of chronic myelogenous leukemia

  • In first relapse after prior complete response

    • Patients who relapsed after autologous or allogeneic bone marrow or peripheral blood stem cell transplantation are not eligible
  • CD33 positive
  • Prior myelodysplastic syndromes or secondary AML allowed
  • Concurrent enrollment on SWOG-9007 (cytogenetics protocol)
  • No clinical or documented CNS involvement with AML

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • WBC no greater than 30,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST or ALT no greater than 1.5 times ULN

Renal

  • Not specified

Cardiovascular

  • No unstable cardiac arrhythmias
  • No unstable angina

Other

  • HIV negative

  • No other malignancy within the past 5 years except for the following:

    • Adequately treated basal cell or squamous cell skin cancer
    • Carcinoma in situ of the cervix
    • Adequately treated stage I or II cancer currently in complete remission
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • No prior gemtuzumab ozogamicin for AML

Chemotherapy

  • Prior hydroxyurea to control high cell counts allowed

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • At least 4 weeks since prior investigational agents and recovered
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049179

  Show 151 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: John E. Godwin, MD, MS Loyola University
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00049179     History of Changes
Other Study ID Numbers: CDR0000257843, S0117, U10CA032102
Study First Received: November 12, 2002
Last Updated: January 12, 2012
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
adult acute monocytic leukemia (M5b)
adult acute erythroid leukemia (M6)
adult acute megakaryoblastic leukemia (M7)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
 recurrent adult acute myeloid leukemia
secondary acute myeloid leukemia
adult acute myeloid leukemia with t(8;21)(q22;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Gemtuzumab
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013