Expired Study
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New York, New York 10032


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill leukemia cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation and interleukin-2 in treating patients who have acute leukemia.


Study summary:

OBJECTIVES: - Determine the efficacy of busulfan, cyclophosphamide, and etoposide followed by autologous peripheral blood stem cell transplantation and interleukin-2 in patients with high-risk acute leukemia. - Determine the efficacy of immunomodulatory therapies in terms of relapse-free survival of these patients treated with this regimen. - Determine the hematopoietic reconstitution, relapse, and survival of these patients treated with this regimen. - Determine the toxicity of this regimen in these patients. OUTLINE: Following a course of mobilization chemotherapy, patients receive priming therapy comprising filgrastim (G-CSF) and interleukin-2 through the completion of leukapheresis. Patients then receive oral busulfan 4 times daily on days -8 through -5, cyclophosphamide IV continuously on days -4 and -3, and etoposide IV over 2 hours on day -4. For patients unable to receive cyclophosphamide and etoposide, melphalan IV is administered instead on days -3 and -2. Autologous peripheral blood stem cells (PBSC) are reinfused on day 0. Patients then receive G-CSF daily beginning on day 0 and continuing until blood counts recover followed by interleukin-2 subcutaneously daily beginning at the completion of G-CSF therapy and continuing for 6 months. Patients are followed weekly for 1 month and then monthly thereafter. PROJECTED ACCRUAL: A total of 19-25 patients will be accrued for this study within 3-5 years.


Criteria:

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed acute leukemia - High-risk due to any of the following: - Cytogenetic abnormalities involving 5q, 7q, 8q, 11q23, or t(9;22) - WBC greater than 100,000/mm3 - Prior myelodysplastic syndrome - Complete remission (CR) lasting less than 12 months - No favorable cytogenetic parameters (e.g., t(15;17), inv16, or t(8;21)) - CR following standard anti-leukemic therapy confirmed by bone marrow evaluation - Second and third CR allowed - Ineligible for higher priority national or institutional study or allogeneic peripheral blood stem cell transplantation PATIENT CHARACTERISTICS: Age: - Any age Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics Hepatic: - Bilirubin less than 1.5 times normal - SGOT or SGPT less than 1.5 times normal Renal: - Creatinine less than 1.5 times normal Cardiovascular: - LVEF at least 45% if receiving cyclophosphamide - Normal electrocardiogram OR - Approval by cardiologist Pulmonary: - DLCO less than 60% predicted OR - Approval by pulmonologist Other: - Not pregnant or nursing - No concurrent illness that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified


NCT ID:

NCT00008190


Primary Contact:

Study Chair
Charles S. Hesdorffer, MD
Herbert Irving Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10032
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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