Combination Chemotherapy in Treating Patients With Recurrent or Refractory Leukemia or Lymphoma
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|ClinicalTrials.gov Identifier: NCT00047021|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 11, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma||Biological: sargramostim Drug: cytarabine Drug: mitoxantrone hydrochloride||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study Of Cytarabine And High-Dose Mitoxantrone For Relapsed Or Refractory Hematologic Malignancies|
|Study Start Date :||November 2001|
|Actual Primary Completion Date :||August 2005|
|Actual Study Completion Date :||September 2005|
- Biological: sargramostim
Sargramostim (GM-CSF) subcutaneously beginning on day 14 and continuing until blood counts recover.
- Drug: cytarabine
high-dose cytarabine IV over 1 hour on days 1-5
- Drug: mitoxantrone hydrochloride
high-dose mitoxantrone IV over 15-30 minutes on day 5.
- Event free survival at day 14 (myeloid engraftment) [ Time Frame: day 14 ]
- Incidence of serious infections by clinical, radiologic, microbiology assessment during and after treatment [ Time Frame: followed for 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00047021
|United States, Ohio|
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-7284|
|Principal Investigator:||Mary J. Laughlin, MD||Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|