Expired Study
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Berkeley Heights, New Jersey 07922


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00017589


Primary Contact:

Study Chair
Stanley R. Frankel, MD
Genta Incorporated


Backup Contact:

N/A


Location Contact:

Berkeley Heights, New Jersey 07922
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

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