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Gemtuzumab Ozogamicin and High-Dose Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006265
  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 high-dose cytarabine in treating patients who have relapsed or refractory acute myeloid leukemia.


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

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood
Drug Information available for: Cytarabine Cytarabine hydrochloride Gemtuzumab ozogamicin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Dose Escalation And Phase II Study Of Gemtuzumab Ozogamicin (CMA-676; Mylotarg) With High-Dose Cytarabine For Patients With Refractory Or Relapsed Acute Myeloid Leukemia (AML)

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2001
Detailed Description:

OBJECTIVES:

  • Determine the response rate in patients with relapsed or refractory acute myeloid leukemia treated with gemtuzumab ozogamicin (CMA-676) and high-dose cytarabine.
  • Determine the safety and toxicity of this regimen in these patients.

OUTLINE: This is a dose-escalation study of gemtuzumab ozogamicin (CMA-676) (phase I closed to accrual effective 08/25/2003). Patients are stratified according to disease status (refractory vs relapsed).

  • Phase I (closed to accrual effective 08/25/2003): Patients are enrolled in one of four cohorts.

    • Cohort I (closed to accrual as of 10/1/02): Patients receive CMA-676 at the first dose level IV over 2 hours on days 1 and 8.
    • Cohort IA (open to accrual as of 10/15/02): Patients receive high-dose cytarabine (HD-ARA-C) IV over 3 hours on days 1-5 and CMA-676 IV over 2 hours on day 7.
    • Cohort II: Patients receive HD-ARA-C as in cohort IA and CMA-676 at the first dose level IV over 2 hours on days 7 and 14.
    • Cohort IV: Patients receive CMA-676 at the second dose level and HD-ARA-C as in cohort II.

Dose escalation stops if at least 3 of 9 patients experience dose-limiting toxicity.

  • Phase II: Patients receive HD-ARA-C IV over 3 hours on days 1-5 and CMA-676 IV over 2 hours on day 7 (one course).

Patients are followed at 1 month, monthly for 6 months, every 3 months for 2 years, and then annually for 10 years.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for phase I of the study and a total of 37 patients will be accrued for phase II of the study within 2 years. (Phase I closed to accrual effective 08/25/2003).

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • One of the following diagnoses:

    • Primary refractory acute myeloid leukemia (AML)

      • More than 10% blasts in the bone marrow or blood after recovery from 2 courses of standard cytarabine- and anthracycline-based induction chemotherapy
      • No prior remission
    • Relapsed AML

      • More than 10% blasts in the bone marrow or blood after documented remission
      • Prior remission lasted more than 30 days
      • No prior treatment for current relapse
  • CD33 expression on at least 20% of leukemia blast cells at initial diagnosis for primary refractory patients or at the time of relapse for all other patients
  • No active CNS involvement

PATIENT CHARACTERISTICS:

Age:

  • 17 and over

Performance status:

  • 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics
  • WBC less than 30,000/mm^3

Hepatic:

  • Bilirubin less than 2.0 mg/dL
  • No veno-occlusive disease of the liver
  • No chronic liver disease unless due to AML

Renal:

  • Not specified

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active serious infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 6 months since prior stem cell transplantation

Chemotherapy:

  • See Disease Characteristics
  • Prior etoposide and/or thioguanine during remission induction allowed
  • Prior hydroxyurea for control of AML allowed
  • At least 24 hours since prior hydroxyurea
  • At least 3 months since prior high-dose cytarabine (greater than 2 g/m^2/dose)-containing regimen
  • No other concurrent chemotherapy

Endocrine therapy:

  • Concurrent steroids for adrenal failure, hypersensitivity reactions, or septic shock allowed
  • Concurrent ophthalmic corticosteroids allowed
  • Concurrent hormones for nondisease-related conditions (e.g., insulin for diabetes or estrogens or progestins for gynecologic conditions) allowed

Radiotherapy:

  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • More than 2 months since prior cytotoxic therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006265

  Show 78 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Richard M. Stone, MD Dana-Farber Cancer Institute
  More Information

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

Publications of Results:
Stone RM, Moser B, Schulman P, et al.: A dose escalation and phase II study of gemtuzumab ozogamicin (GO) with high-dose cytarabine (HiDAC) for patients (pts) with refractory or relapsed acute myeloid leukemia (AML): CALGB 19902. [Abstract] Blood 104 (11): A-873, 2004.

Study ID Numbers: CDR0000068208, CALGB-19902
Study First Received: September 11, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00006265  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult acute myeloid leukemia

Study placed in the following topic categories:
Antibodies, Monoclonal
Leukemia
Antibodies
Acute myelogenous leukemia
Acute myeloid leukemia, adult
Leukemia, Myeloid
Gemtuzumab
Leukemia, Myeloid, Acute
Acute myelocytic leukemia
Cytarabine
Recurrence
Immunoglobulins

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

ClinicalTrials.gov processed this record on January 16, 2009