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

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
filgrastim
sargramostim
cytarabine
mitoxantrone hydrochloride
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring recurrent adult acute myeloid leukemia, recurrent childhood acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, recurrent childhood acute lymphoblastic leukemia

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 27, 2003
Last Updated
March 7, 2011
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00053131
Brief Title
Combination Chemotherapy Followed By Filgrastim or Sargramostim in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
February 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
recurrent adult acute myeloid leukemia, recurrent childhood acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, recurrent childhood acute lymphoblastic leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Biological
Intervention Name(s)
sargramostim
Intervention Type
Drug
Intervention Name(s)
cytarabine
Intervention Type
Drug
Intervention Name(s)
mitoxantrone hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria R. Baer, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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