NCT00047021

Combination Chemotherapy in Treating Patients With Recurrent or Refractory Leukemia or Lymphoma

A Pilot Study Of Cytarabine And High-Dose Mitoxantrone For Relapsed Or Refractory Hematologic Malignancies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Leukemia
• Lymphoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2001-11-01
• Primary completion: 2005-08-01
• Completion: 2005-09-01
• First posted: 2003-01-27
• Last updated: 2010-06-11

Locations

1 site across 1 country: United States