Expired Study
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Cleveland, Ohio 44106


Purpose:

RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral stem cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related donor, that do not exactly match the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. PURPOSE: This phase II trial is studying how well giving chemotherapy with or without radiation therapy followed by donor stem cell transplant works in treating patients with hematologic cancer.


Study summary:

OBJECTIVES: - Determine a standard approach to hematopoietic stem cell transplantation with matched unrelated donors in patients with hematologic malignancies. - Determine the toxicity of this regimen in these patients. - Determine the relapse rate and survival rate in patients treated with this regimen. - Correlate incidence and severity of graft-versus-host disease with relapse and survival in patients treated with this regimen. OUTLINE: Patients receive 1 of the following preparative regimens: - Regimen A: Patients receive cytarabine IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1. - Regimen B: Patients receive cyclophosphamide IV and TBI as in regimen A. - Regimen B2: Patients receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1. - Regimen C: Patients receive oral busulfan 4 times daily on days -8 to -5 and cyclophosphamide IV over 2 hours on days -4 to -2. All patients undergo stem cell transplantation from a matched, unrelated donor on day 0. Patients are followed weekly for 100 days, at 6 months, and then every 6 months for 2.5 years. PROJECTED ACCRUAL: 50


Criteria:

DISEASE CHARACTERISTICS: - One of the following histologically confirmed diseases: - Acute myeloid leukemia (AML) - In first, second, or greater remission - In early relapse (less than 30% marrow blasts) - Acute lymphoblastic leukemia (ALL) - In second or greater complete remission - High-risk ALL in first complete remission, defined by 1 of the following factors: - t(4;11), t(9;22), or t(8;14) translocation - Extreme hyperleukocytosis (WBC greater than 500,000/mL) at presentation - Failure to achieve a complete remission after standard induction therapy - Chronic myelogenous leukemia - Myelodysplastic syndromes - Evolution to AML included - Refractory anemia with excess blasts (RAEB) - RAEB in transformation - Intermediate or high-grade lymphoma - Complete response (CR) or partial response (PR) after first or greater relapse OR - PR only after first-line therapy NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age - 55 and under Performance status - ECOG 0-2 OR - Lansky 80-100% Life expectancy - At least 3 months Hematopoietic - See Disease Characteristics Hepatic - Bilirubin less than 2.5 mg/dL - AST less than 4 times upper limit of normal - No chronic active hepatitis Renal - Creatinine no greater than 2.0 mg/dL - Creatinine clearance at least 50 mL/min by 24-hour urine collection Cardiovascular - Resting ejection fraction at least 50% - Shortening fraction greater than 28% (for small children) - No angina requiring treatment - No congestive heart failure requiring treatment - No myocardial infarction within the past year Pulmonary - FEV_1 at least 50% of predicted - Arterial partial pressure of oxygen at least 80 mm Hg by pulmonary function testing - Diffusion capacity at least 50% of predicted Other - Not pregnant or nursing - Negative pregnancy test - HIV negative - No uncontrolled diabetes mellitus - No active infection, including any of the following: - Soft tissue infection - Sinus infection - Dental infection - Fungal infection - No significant psychiatric illness that would preclude study participation - No medical complication that makes the risk of death during transplantation from nonmalignant causes greater than the risk of relapse PRIOR CONCURRENT THERAPY: Biologic therapy - At least 1 year since prior stem cell transplantation Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified


NCT ID:

NCT00054327


Primary Contact:

Principal Investigator
Kenneth Cooke, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44106
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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