Combination Chemotherapy Followed By Filgrastim or Sargramostim in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia - Article
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.
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 |
Procedure: biological response modifier therapy
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
- Compare amounts of dendritic cells and leukemia-associated antigen-specific T lymphocytes in patients with relapsed or refractory acute myeloid leukemia or acute lymphoblastic leukemia treated with filgrastim (G-CSF) vs sargramostim (GM-CSF) after high-dose cytarabine and mitoxantrone.
OUTLINE: This is a randomized study.
- 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
- Diagnosis of acute myeloid leukemia or acute lymphoblastic leukemia by morphology, cytochemical staining, and flow cytometry
- In first or subsequent relapse or refractory disease after at least 1 prior treatment regimen
- Antecedent hematologic disorders allowed except Philadelphia chromosome-positive chronic myelogenous leukemia
PATIENT CHARACTERISTICS: Age
- 15 and over
- 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
PRIOR CONCURRENT THERAPY: Biologic therapy
- Prior autologous or allogeneic bone marrow or peripheral blood stem cell transplantation allowed
- Prior cytokines allowed
- Prior chemotherapy allowed
- No concurrent corticosteroids except for treatment of severe vomiting that is refractory to standard agents
- Prior radiotherapy allowed
- Not specified
Roswell Park Cancer Institute, Buffalo, New York, 14263-0001, United States
Maria R. Baer, MD, Study Chair, Roswell Park Cancer Institute
Record last reviewed: April 2004
Last Updated: October 13, 2004
Record first received: January 27, 2003
ClinicalTrials.gov Identifier: NCT00053131
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005