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

Primary Purpose

Leukemia, Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sargramostim
cytarabine
mitoxantrone hydrochloride
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, recurrent adult acute lymphoblastic leukemia, recurrent adult acute myeloid leukemia, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult Hodgkin lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent childhood acute lymphoblastic leukemia, recurrent childhood acute myeloid leukemia, recurrent childhood large cell lymphoma, recurrent childhood lymphoblastic lymphoma, recurrent childhood small noncleaved cell lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent/refractory childhood Hodgkin lymphoma, relapsing chronic myelogenous leukemia, secondary acute myeloid leukemia, childhood chronic myelogenous leukemia, atypical chronic myeloid leukemia, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with t(15;17)(q22;q12)

Eligibility Criteria

undefined - 55 Years (Child, Adult)All SexesDoes not accept 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 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

Sites / Locations

  • Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Event free survival at day 14 (myeloid engraftment)

Secondary Outcome Measures

Incidence of serious infections by clinical, radiologic, microbiology assessment during and after treatment

Full Information

First Posted
October 3, 2002
Last Updated
June 10, 2010
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00047021
Brief Title
Combination Chemotherapy in Treating Patients With Recurrent or Refractory Leukemia or Lymphoma
Official Title
A Pilot Study Of Cytarabine And High-Dose Mitoxantrone For Relapsed Or Refractory Hematologic Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma
Keywords
accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, recurrent adult acute lymphoblastic leukemia, recurrent adult acute myeloid leukemia, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult Hodgkin lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent childhood acute lymphoblastic leukemia, recurrent childhood acute myeloid leukemia, recurrent childhood large cell lymphoma, recurrent childhood lymphoblastic lymphoma, recurrent childhood small noncleaved cell lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent/refractory childhood Hodgkin lymphoma, relapsing chronic myelogenous leukemia, secondary acute myeloid leukemia, childhood chronic myelogenous leukemia, atypical chronic myeloid leukemia, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with t(15;17)(q22;q12)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
sargramostim
Intervention Description
Sargramostim (GM-CSF) subcutaneously beginning on day 14 and continuing until blood counts recover.
Intervention Type
Drug
Intervention Name(s)
cytarabine
Intervention Description
high-dose cytarabine IV over 1 hour on days 1-5
Intervention Type
Drug
Intervention Name(s)
mitoxantrone hydrochloride
Intervention Description
high-dose mitoxantrone IV over 15-30 minutes on day 5.
Primary Outcome Measure Information:
Title
Event free survival at day 14 (myeloid engraftment)
Time Frame
day 14
Secondary Outcome Measure Information:
Title
Incidence of serious infections by clinical, radiologic, microbiology assessment during and after treatment
Time Frame
followed for 3 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary J. Laughlin, MD
Organizational Affiliation
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-7284
Country
United States

12. IPD Sharing Statement

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

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