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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


Phase 2
15 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Maria R. Baer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000269285

NCT ID:

NCT00053131

Start Date:

January 1999

Completion Date:

February 2004

Related Keywords:

  • Leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • recurrent childhood acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263