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



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

For Condition: recurrent adult acute myeloid leukemia
Status: No longer recruiting
Sponsor(s): Genta ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 60 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
StanleyFrankel,  Study Chair,  Genta

Genta Incorporated
Berkeley Heights,  New Jersey,  07922
United States
 


Additional Information:
Study ID Numbers:
  CDR0000068721;  UCCRC-10928,GENTA-GA210
Study Start Date: 
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017589

Other Recurrent Adult Acute Myeloid Leukemia Studies:
1. Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia

2. Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia

3. Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia

4. Graft-Versus-Host Disease Prevention in Treating Patients Who Are Undergoing Bone Marrow Transplantation

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

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