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

Sponsor

Case Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00047021

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia Lymphoma	Biological: sargramostim Drug: cytarabine Drug: mitoxantrone hydrochloride	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2001

Actual Primary Completion Date :

Aug 1, 2005

Actual Study Completion Date :

Sep 1, 2005

Outcome Measures

Primary Outcome Measures

Event free survival at day 14 (myeloid engraftment) [day 14]

Secondary Outcome Measures

Incidence of serious infections by clinical, radiologic, microbiology assessment during and after treatment [followed for 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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