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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00047021
First received: October 3, 2002
Last updated: June 10, 2010
Last verified: June 2010
  Purpose

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 Intervention Phase
Leukemia
Lymphoma
Biological: sargramostim
Drug: cytarabine
Drug: mitoxantrone hydrochloride
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study Of Cytarabine And High-Dose Mitoxantrone For Relapsed Or Refractory Hematologic Malignancies

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Event free survival at day 14 (myeloid engraftment) [ Time Frame: day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of serious infections by clinical, radiologic, microbiology assessment during and after treatment [ Time Frame: followed for 3 months ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: November 2001
Study Completion Date: September 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   up to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00047021

Locations
United States, Ohio
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-7284
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Mary J. Laughlin, MD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Mary J. Laughlin, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00047021     History of Changes
Other Study ID Numbers: CWRU5Y01, P30CA043703, CWRU-5Y01, NCI-G02-2113, CWRU-11021P, CASE-5Y01
Study First Received: October 3, 2002
Last Updated: June 10, 2010
Health Authority: United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:
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

Additional relevant MeSH terms:
Leukemia
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Mitoxantrone
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 22, 2014