Combination Chemotherapy Followed By Filgrastim or Sargramostim in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia - Full Text View

Sponsor:	Roswell Park Cancer Institute
Information provided by:	Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT00053131

Purpose

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: Randomized phase 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 refractory acute myeloid leukemia or acute lymphoblastic leukemia.

Condition	Intervention	Phase
Leukemia	Biological: filgrastim Biological: sargramostim Drug: cytarabine Drug: mitoxantrone hydrochloride	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	High Dose Cytarabine And Mitoxantrone Therapy For Relapsed And Refractory Acute Myeloid And Lymphocytic Leukemia: Effects Of GM-CSF Versus G-CSF On Dendritic Cells And Leukemia Associated Antigen-Specific T-Lymphocytes

Resource links provided by NLM:

MedlinePlus related topics: Acute Lymphocytic Leukemia Acute Myeloid Leukemia Cancer Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: Cytarabine hydrochloride Mitoxantrone Mitoxantrone hydrochloride Granulocyte-macrophage colony-stimulating factor Filgrastim Sargramostim Lenograstim Granulocyte colony-stimulating factor Cytarabine

U.S. FDA Resources

Further study details as provided by Roswell Park Cancer Institute:

Study Start Date:	January 1999
Study Completion Date:	February 2004
Primary Completion Date:	February 2004 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

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.

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.

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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

Performance status

0-3

Life expectancy

At least 4 weeks

Hematopoietic

Not specified

Hepatic

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

Renal

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

Cardiovascular

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

Other

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

Chemotherapy

Prior chemotherapy allowed

Endocrine therapy

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

Radiotherapy

Prior radiotherapy allowed

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053131

Locations

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

Sponsors and Collaborators

Roswell Park Cancer Institute

Investigators

Study Chair:

Maria R. Baer, MD

Roswell Park Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Maria Bear, MD, Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT00053131 History of Changes
Other Study ID Numbers:	CDR0000269285, RPCI-RPC-9902
Study First Received:	January 27, 2003
Last Updated:	March 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:

recurrent adult acute myeloid leukemia
recurrent childhood acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
recurrent childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Mitoxantrone
Lenograstim
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
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on February 12, 2012