Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Cleveland, Ohio 44106


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.


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



Primary Contact:

Principal Investigator
Mary J. Laughlin, MD
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Backup Contact:


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: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.