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Gemtuzumab Ozogamicin in Treating Patients With Relapsed Acute Myeloid Leukemia After Stem Cell Transplantation



Gemtuzumab Ozogamicin in Treating Patients With Relapsed Acute Myeloid Leukemia After Stem Cell Transplantation

For Condition: recurrent adult acute myeloid leukemia,recurrent childhood acute myeloid leukemia,secondary acute myeloid leukemia
Status: Recruiting
Sponsor(s): Ireland Cancer Center , National Cancer Institute (NCI)
Synopsis: 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. PURPOSE: Phase I trial to study the effectiveness of gemtuzumab ozogamicin in treating patients who have relapsedacute myeloid leukemia after stem cell transplantation.
Details: OBJECTIVES: - Determine the maximum tolerated dose of gemtuzumab ozogamicin in patients with relapsed CD33-positive acute myeloid leukemia who have received a prior hematopoietic stem cell transplantation. - Determine the safety of this drug in these patients. - Assess the efficacy of this drug, in terms of attainment of a complete response or morphological remission, in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to type of prior stem cell transplantation (allogeneic vs autologous). Patients receive gemtuzumab ozogamicin IV over 2 hours. Treatment repeats every 14-28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients per stratum receive escalating doses of gemtuzumab ozogamicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients who achieve complete or partial remission may receive up to 4 additional courses of gemtuzumab ozogamicin beginning within 28-70 days of the second course. Patients are followed monthly for 6 months, every 3 months for 18 months, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within approximately 18 months.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of CD33-positive acute myeloid leukemia by flow cytometry - Relapsed after autologous or allogeneic hematopoietic stem cell transplantation (HSCT) - Pretransplant history of myelodysplastic syndromes allowed if the proportion of myeloblasts exceeds 5% by marrow aspirate - Must be at least 60 days post-HSCT - No active CNS leukemia - No active testicular leukemia PATIENT CHARACTERISTICS: Age - Any age Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - See Disease Characteristics - WBC less than 30,000/mm - Hydroxyurea allowed for reduction if discontinued 24 hours prior to study Hepatic - Bilirubin no greater than 2.0 mg/dL - No prior clinical veno-occlusive disease of the liver as manifested by a greater than 5% increase in weight over baseline and any total bilirubin greater than 5 mg/dL within the first 20 days post transplantation Renal - Creatinine no greater than 2.5 mg/dL Cardiovascular - Cardiac ejection fraction at least 30% - No cardiac failure requiring therapy Pulmonary - DLCO at least 35% and not receiving supplementary continuous oxygen Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No concurrent uncontrolled infections - No other concurrent active malignancy PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No prior anti-CD33 antibodies - No concurrent cytokines (except for a life-threatening infection due to neutropenia) Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - At least 24 hours since prior acetaminophen - At least 4 weeks since prior investigational/conventional antileukemic agents - No other concurrent anticancer therapy
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
MaryLaughlin,  Study Chair,  Ireland Cancer Center

Ireland Cancer Center *Recruiting*
Cleveland,  Ohio,  44106-5065
United States
Recruiting Mary  Laughlin 216-844-8609


Additional Information:
Study ID Numbers:  CDR0000269342;  CWRU-WAGM-1901,W-AR-0903X-100374-US
Study Start Date: 
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053274

Other Secondary Acute Myeloid Leukemia Studies:
1. Chemotherapy Followed by Donor White Blood Cells Plus Interleukin-2 in Treating Patients With Acute Myeloid or Lymphocytic Leukemia

2. Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia

3. PS-341 in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia in Blast Phase, or Myelodysplastic Syndrome

4. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Low-Dose Interleukin-2 in Treating Patients With Acute Myelogenous Leukemia

5. Decitabine and Valproic Acid in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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Gemtuzumab Ozogamicin in Treating Patients With Relapsed Acute Myeloid Leukemia After Stem Cell Transplantation
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