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

This study has been completed.
Sponsor:
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00053131
First received: January 27, 2003
Last updated: March 7, 2011
Last verified: March 2011
  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 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Topoisomerase II Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014