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

Study Overview
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Brief Summary
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RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Oblimersen may help gemtuzumab ozogamicin kill more cancer cells by making cancer cells more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of combining oblimersen and gemtuzumab ozogamicin in treating older patients who have relapsed acute myeloid leukemia.

Detailed Description
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OBJECTIVES: Determine the complete response rate of elderly patients with relapsed CD33-positive acute myeloid leukemia treated with oblimersen and gemtuzumab ozogamicin. Determine the overall response rate and duration of response of patients treated with this regimen. Determine the safety of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive oblimersen IV continuously on days 1-7 and 15-22 and gemtuzumab ozogamicin IV over 2 hours on days 4 and 18. Patients are followed monthly for 6 months. PROJECTED ACCRUAL: A total of 20-100 patients will be accrued for this study within 1 year.

Official Title
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Phase II Study of Genasense (Bcl-2 Antisense) Combined With Mylotarg (Gemtuzumab Ozogamicin) in Elderly Patients With Relapsed Acute Myeloid Leukemia

Conditions
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Leukemia

Intervention / Treatment
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* Biological: oblimersen sodium
* Drug: gemtuzumab ozogamicin


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed CD33+ acute myeloid leukemia (AML) In first relapse from chemotherapy Complete response lasting at least 3 months before relapse No CNS leukemia No secondary leukemia or history of antecedent hematologic disorder prior to initial onset of AML (e.g., myelodysplasia) PATIENT CHARACTERISTICS: Age: 60 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC less than 30,000/mm^3 No bleeding or coagulation disorder except disease-related disseminated intravascular coagulation Hepatic: Bilirubin no greater than 1.5 mg/dL PT and PTT no greater than 1.5 times upper limit of normal OR INR no greater than 1.3 No history of chronic hepatitis or cirrhosis Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No uncontrolled congestive heart failure No New York Heart Association class III or IV heart disease Pulmonary: No severe pulmonary disease Other: HIV negative No other concurrent medical disease that would preclude study entry No known hypersensitivity to phosphorothioate-containing oligonucleotides, gemtuzumab ozogamicin or any of its components, E. coli protein, or any product produced in E. coli No other concurrent malignancy No known human anti-human antibodies No uncontrolled seizure disorder No active uncontrolled infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior allogeneic or autologous stem cell transplantation No prior therapy with an anti-CD33 antibody (e.g., gemtuzumab ozogamicin or M195) Chemotherapy: See Disease Characteristics At least 2 weeks since prior cancer chemotherapy except intrathecal chemotherapy or hydroxyurea Endocrine therapy: Not specified Radiotherapy: At least 2 weeks since prior systemic radiotherapy Surgery: At least 2 weeks since prior major surgery No prior organ allograft Other: At least 3 weeks since prior antileukemic therapy and recovered No other concurrent investigational therapy No concurrent immunosuppressive therapy

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: oblimersen sodium|nan|
|Drug: gemtuzumab ozogamicin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent adult acute myeloid leukemia