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Combination Chemotherapy in Treating Patients With Recurrent or Refractory Leukemia or Lymphoma
This study has been completed.
First Received: October 3, 2002   Last Updated: February 6, 2009   History of Changes
Sponsor: Ireland Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00047021
  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 II

Study Type: Interventional
Study Design: 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 National Cancer Institute (NCI):

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

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

Study Start Date: November 2001
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047021

Locations
United States, Ohio
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland, Ohio, United States, 44106-7284
Sponsors and Collaborators
Ireland Cancer Center
Investigators
Study Chair: Mary J. Laughlin, MD Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000257234, CWRU-5Y01, NCI-G02-2113, CWRU-11021P, CASE-5Y01
Study First Received: October 3, 2002
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00047021     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Leukemia
Sensory System Agents
Therapeutic Uses
Analgesics
Lymphoma
Cytarabine
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Mitoxantrone
Peripheral Nervous System Agents
Lymphoproliferative Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 09, 2009