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Protocol for Treatment of Newly Diagnosed High Risk And Relapsed Acute Myeloid Leukemia and Blastic Crisis Chronic Myelogenous Leukemia With Ethyol and High-Dose Cytarabine + Mitoxantron Followed by Maintenance Phase Using Low-Dose ARA-C, rhGM-CSF, Pentoxifylline, Ciprofloxacin and Decadron


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Drug/Agent Toxicity by Tissue/Organ, Leukemia, Myelodysplastic Syndromes, Neutropenia

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Trial Information

Protocol for Treatment of Newly Diagnosed High Risk And Relapsed Acute Myeloid Leukemia and Blastic Crisis Chronic Myelogenous Leukemia With Ethyol and High-Dose Cytarabine + Mitoxantron Followed by Maintenance Phase Using Low-Dose ARA-C, rhGM-CSF, Pentoxifylline, Ciprofloxacin and Decadron


OBJECTIVES: I. Assess the effects of amifostine on the response to remission induction
therapy and consolidation with cytarabine and mitoxantrone in patients with poor prognosis
acute myeloid leukemia (AML), relapsed AML, and blastic phase chronic myelogenous leukemia
(CML). II. Assess the effects of amifostine on the biology of AML and CML cells in vivo in
this patient population.

OUTLINE: Patients receive treatment prior to induction therapy on protocols CYL 90-03 and
CYL 97-59. Induction therapy consists of amifostine IV on days 1 and 5 and three times a
week from days 6 to 28. Fifteen minutes after amifostine on days 1 and 5, patients receive
cytarabine IV over 3 hours at hour 0 and hour 12 and mitoxantrone IV over 1 hour at hour 15.
Patients who do not enter remission receive a second course of induction therapy. Patients
with persistent AML following a second course are removed from the study. Patients who
achieve a complete response (CR), clinical CR, or remission in bone marrow but without
hematologic recovery or who return to myelodysplastic syndrome receive consolidation
therapy. Consolidation therapy consists of amifostine IV on days 1 and 5 and then three
times a week until blood counts recover or day 30, whichever comes first. Patients also
receive cytarabine and mitoxantrone as in induction therapy. Patients receive a second
course of consolidation therapy beginning 1 week after blood counts recover. After
completion of consolidation therapy, patients are enrolled on protocol MDS 97-53.

PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Newly diagnosed high risk acute myeloid leukemia (AML) defined
as: AML after myelodysplastic syndrome; refractory anemia with excess blasts in
transformation or "AML in evolution" also eligible AML following a chronic
myeloproliferative disorder (except chronic myelogenous leukemia) Therapy related AML or
AML following exposure to a known hematopoietic toxin Relapsed AML Age 70 or older OR AML
in first relapse defined as: AML in first relapse without treatment on protocol AML-9801
Relapsed following standard chemotherapy Previously treated on AML-9701 and relapsed after
at least 6 months of remission OR Chronic myelogenous leukemia (CML) in blast crisis
defined as: 20% or more blast cells in the bone marrow or peripheral blood Pure lymphoid
blastic crisis eligible if resistant to an acute lymphocytic leukemia type treatment
regimen or relapsed after initial response to such a treatment

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 3
mg/dL SGOT/SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine less
than 3 mg/dL Cardiovascular: No overt congestive heart failure or uncontrollable
ventricular arrhythmias No uncontrollable hypertension Neurologic: No cerebellar
dysfunction Other: Not pregnant or nursing Negative pregnancy test Fertile patients must
use effective contraception

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Philip D. Bonomi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Rush University Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000066416

NCT ID:

NCT00003407

Start Date:

April 1998

Completion Date:

Related Keywords:

  • Drug/Agent Toxicity by Tissue/Organ
  • Leukemia
  • Myelodysplastic Syndromes
  • Neutropenia
  • recurrent adult acute myeloid leukemia
  • blastic phase chronic myelogenous leukemia
  • untreated adult acute myeloid leukemia
  • refractory anemia with excess blasts in transformation
  • secondary acute myeloid leukemia
  • de novo myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • drug/agent toxicity by tissue/organ
  • neutropenia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Myelodysplastic Syndromes
  • Preleukemia
  • Neutropenia

Name

Location

Rush Cancer InstituteChicago, Illinois  60612
Angelo P. Creticos, M.D. Cancer CenterChicago, Illinois  60657
Cook County HospitalChicago, Illinois  60612-9985
Rush-Riverside Cancer CenterKankakee, Illinois  60901