Clinical Trial: Combination Chemotherapy Followed By Filgrastim or Sargramostim in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

This study is no longer recruiting patients.

Sponsors and Collaborators: Roswell Park Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)


RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim and sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. It is not yet known whether combination chemotherapy is more effective followed by filgrastim or sargramostim in treating leukemia.

PURPOSE: Randomizedphase II trial to compare the effectiveness of combination chemotherapy followed by filgrastim with that of combination chemotherapy followed by sargramostim in treating patients who have relapsed or refractoryacute myeloid leukemia or acute lymphoblastic leukemia.

Condition Treatment or Intervention Phase
recurrent adult acute myeloid leukemia
recurrent childhood acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
recurrent childhood acute lymphoblastic leukemia
 Drug: cytarabine
 Drug: filgrastim
 Drug: mitoxantrone
 Drug: sargramostim
 Procedure: biological response modifier therapy
 Procedure: chemotherapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Procedure: high-dose chemotherapy
Phase II

MedlinePlus related topics:  Bone Marrow Diseases;   Immune System and Disorders;   Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphatic Diseases

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Randomized Study of High-Dose Cytarabine and Mitoxantrone Followed By Filgrastim (G-CSF) Versus Sargramostim (GM-CSF) in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

Further Study Details: 


OUTLINE: This is a randomized study.

All patients receive high-dose cytarabine IV over 1 hour twice daily on days 1-6 and mitoxantrone IV over 30 minutes on days 2-4. On day 6, patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive filgrastim (G-CSF) subcutaneously (SC) daily until blood counts recover in the absence of unacceptable toxicity.
  • Arm II: Patients receive sargramostim (GM-CSF) SC daily as in arm I.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 6 years.


Ages Eligible for Study:  15 Years and above,  Genders Eligible for Study:  Both




  • 15 and over

Performance status

  • 0-3

Life expectancy

  • At least 4 weeks


  • Not specified


  • Bilirubin no greater than 2 times normal*
  • SGOT no greater than 2 times normal* NOTE: *Unless directly attributable to leukemia


  • Creatinine no greater than 1.5 times normal* NOTE: *Unless directly attributable to leukemia


  • Ejection fraction at least 45%* NOTE: *Unless directly attributable to leukemia


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other concurrent medical or psychiatric illness that would preclude study entry



Endocrine therapy

  • No concurrent corticosteroids except for treatment of severe vomiting that is refractory to standard agents



  • Not specified

Location Information

New York
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States

Study chairs or principal investigators

Maria R. Baer, MD,  Study Chair,  Roswell Park Cancer Institute   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000269285; RPCI-RPC-9902
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  January 27, 2003 Identifier:  NCT00053131
Health Authority: Unspecified processed this record on 2005-04-08

Cache Date: April 9, 2005