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Treatment Protocol for Patients With Standard Risk Acute Myelogenous Leukemia and Its Variants: Induction Using High-Dose Cytarabine, Mitoxantrone and Ethyol; Consolidation With Cytarabine and Idarubicin and Maintenance With 13 Cis Retinoic Acid and Alpha Interferon


Phase 2
N/A
70 Years
Open (Enrolling)
Both
Leukemia

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Trial Information

Treatment Protocol for Patients With Standard Risk Acute Myelogenous Leukemia and Its Variants: Induction Using High-Dose Cytarabine, Mitoxantrone and Ethyol; Consolidation With Cytarabine and Idarubicin and Maintenance With 13 Cis Retinoic Acid and Alpha Interferon


OBJECTIVES: I. Assess the efficacy of high dose cytarabine with mitoxantrone and amifostine
as induction therapy for patients with previously untreated standard risk acute myelogenous
leukemia (AML). II. Assess the effects of amifostine on the biology of AML cells in vivo in
these patients. III. Determine whether there is a relationship between cytokine production
before and during remission induction therapy and treatment outcome.

OUTLINE: Prior to treatment, patients undergo bone marrow aspirate and biopsy. On day -3,
patients receive idoxuridine IV over 60 minutes followed immediately by a bone marrow
aspirate and biopsy. Patients then receive amifostine IV over 5-7 minutes on the same day.
Prior to chemotherapy on day 1, patient receive broxuridine IV over 60 minutes immediately
followed by bone marrow aspirate and biopsy. Chemotherapy on day 1 consists of amifostine
followed by cytarabine IV over 3 hours repeated every 12 hours and mitoxantrone IV over 1
hour immediately after the second infusion of cytarabine. This course is repeated on day 5
after another bone marrow biopsy and aspirate. Starting on day 6, patients receive
amifostine 3 times a week until day 28 or beyond. Patients who respond to treatment continue
on to receive three courses of consolidation therapy. Consolidation courses 1 and 3 consist
of cytarabine continuous IV on days 1-7 and idarubicin IV over 30 minutes on days 1, 2, and
3. Consolidation course 2 consists of cytarabine IV over 75 minutes repeated every 12 hours
for 4 days. Twenty-four hours after each course of consolidation therapy, patients receive
isotretinoin orally every day and interferon alfa subcutaneously every other day.
Isotretinoin and interferon alfa therapy are stopped 4 days prior to day 1 of the next
course of consolidation therapy. Following recovery from course 3 of consolidation therapy,
patients continue to receive isotretinoin/interferon alfa until relapse. Patients in
complete remission after the 3 courses of consolidation therapy receive
isotretinoin/interferon alfa for 3 years. Patients are followed every 3 months for the first
year, then every 6 months for the next 2 years.

PROJECTED ACCRUAL: There will be 40-45 patients accrued into this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed previously untreated acute myelogenous
leukemia (AML) FAB M1, M2, M4, M5, M6, or M7 No AML secondary to chemotherapy, radiation
therapy, or toxic agents No history of myelodysplastic syndromes If possible, patient
should be enrolled on protocol RUSH-CYL-9003

PATIENT CHARACTERISTICS: Age: 70 and under Performance status: 0-3 Life expectancy: Not
specified Hematopoietic: Not specified Hepatic: Bilirubin greater than 2.0 mg/dL and no
greater than 3.0 mg/dL allowed with 50% reduction in drug doses Renal: Creatinine less
than 3.0 mg/dL Cardiovascular: No overt congestive heart failure No uncontrollable
ventricular arrhythmias No uncontrollable hypertension If cardiac ejection fraction is
less than 45% of predicted, an echocardiogram and a cardiac consult must be obtained to
ascertain cardiac tolerance of anthracycline therapy Neurological: No cerebellar
dysfunction Other: Fever, infection, or other complications of disease allowed Not
pregnant or nursing Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior interferon At
least 2 weeks since prior hematopoietic growth factors (including erythropoietin)
Chemotherapy: At least 2 weeks since prior chemotherapy Endocrine therapy: At least 2
weeks since prior steroids Radiotherapy: Not specified Surgery: Not specified Other: At
least 2 weeks since prior retinoids

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Philip D. Bonomi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Rush University Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000066413

NCT ID:

NCT00003405

Start Date:

April 1998

Completion Date:

Related Keywords:

  • Leukemia
  • untreated adult acute myeloid leukemia
  • untreated childhood acute myeloid leukemia and other myeloid malignancies
  • adult acute erythroid leukemia (M6)
  • adult acute myeloblastic leukemia without maturation (M1)
  • adult acute myeloblastic leukemia with maturation (M2)
  • adult acute myelomonocytic leukemia (M4)
  • adult acute monoblastic leukemia (M5a)
  • adult acute megakaryoblastic leukemia (M7)
  • childhood acute myeloblastic leukemia without maturation (M1)
  • childhood acute myeloblastic leukemia with maturation (M2)
  • childhood acute myelomonocytic leukemia (M4)
  • childhood acute monoblastic leukemia (M5a)
  • childhood acute monocytic leukemia (M5b)
  • childhood acute erythroleukemia (M6)
  • childhood acute megakaryocytic leukemia (M7)
  • adult acute monocytic leukemia (M5b)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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