Full Text View
Tabular View
No Study Results Posted
Related Studies
Combination Chemotherapy in Treating Patients With Recurrent or Refractory Leukemia or Lymphoma
This study has been completed.
Study NCT00047021   Information provided by National Cancer Institute (NCI)
First Received: October 3, 2002   Last Updated: February 6, 2009   History of Changes

October 3, 2002
February 6, 2009
November 2001
 
Event free survival at day 14 (myeloid engraftment) [ Designated as safety issue: No ]
Event free survival at day 14 (myeloid engraftment)
Complete list of historical versions of study NCT00047021 on ClinicalTrials.gov Archive Site
Incidence of serious infections by clinical, radiologic, microbiology assessment during and after treatment [ Designated as safety issue: No ]
Incidence of serious infections by clinical, radiologic, microbiology assessment during and after treatment
 
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

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.

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.

Phase II
Interventional
Treatment
  • Leukemia
  • Lymphoma
  • Biological: sargramostim
  • Drug: cytarabine
  • Drug: mitoxantrone hydrochloride
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
up to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00047021
 
CDR0000257234, CWRU-5Y01, NCI-G02-2113, CWRU-11021P, CASE-5Y01
Ireland Cancer Center
National Cancer Institute (NCI)
Study Chair: Mary J. Laughlin, MD Case Comprehensive Cancer Center
National Cancer Institute (NCI)
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP