Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Southwest Oncology Group

John Edward Godwin

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00049179
Information obtained from ClinicalTrials.gov on January 16, 2012

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