Expired Study
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Cleveland, Ohio 44106


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining cytarabine and mitoxantrone in treating patients who have recurrent or refractory leukemia or lymphoma.


Study summary:

OBJECTIVES: - Determine non-hematologic toxic effects of high-dose cytarabine and high-dose mitoxantrone in patients with recurrent or refractory leukemia or lymphoma. - Determine the in vitro T/NK lymphocyte proliferative responses to patient's leukemia/lymphoma cells before and after treatment with this regimen. OUTLINE: Patients receive high-dose cytarabine IV over 1 hour on days 1-5 and high-dose mitoxantrone IV over 15-30 minutes on day 5. Patients also receive sargramostim (GM-CSF) subcutaneously beginning on day 14 and continuing until blood counts recover. Patients who achieve at least stable disease or a response may receive a second course beginning at least 14 days after the first course is completed. Patients are followed for 3 months. PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within approximately 2-3 years.


Criteria:

DISEASE CHARACTERISTICS: - One of the following must be present: - Histologically confirmed acute myeloid leukemia or acute lymphoblastic leukemia - More than 5% blasts in the bone marrow or peripheral blood unrelated to recovery of normal hematopoiesis from prior chemotherapy - Failed at least 1 attempt at induction chemotherapy - Diagnosis of non-Hodgkin's lymphoma or Hodgkin's lymphoma - Refractory or relapsed after at least 1 regimen of standard chemotherapy - Diagnosis of chronic myelogenous leukemia in accelerated phase or blast crisis - Received at least 1 myelotoxic chemotherapy regimen - Active CNS involvement allowed PATIENT CHARACTERISTICS: Age - 55 and under Performance status - ECOG 0-2 Life expectancy - At least 5 weeks Hematopoietic - Lymphoma patients: - WBC at least 2,000/mm^3* - Platelet count at least 20,000/mm^3* NOTE: *Unless due to bone marrow involvement or disease process Hepatic - Bilirubin no greater than 3 times normal* - AST/ALT no greater than 3 times normal* - Alkaline phosphatase no greater than 3 times normal* - No severe liver failure NOTE: *Unless related to leukemia Renal - Creatinine clearance greater than 50 mL/min - No severe renal failure Cardiovascular - LVEF at least 45% by MUGA Pulmonary - DLCO at least 60% of predicted Other - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No psychiatric illness that would preclude informed consent - No medical illness or other condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - At least 24 hours since prior hydroxyurea - At least 1 week since other prior chemotherapy Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - Recovered from prior therapy


NCT ID:

NCT00047021


Primary Contact:

Principal Investigator
Mary J. Laughlin, MD
Ireland Cancer Center at University Hospitals Case Medical 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: December 11, 2017

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