Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy Plus Biological Therapy in Treating Patients With Acute Myelogenous Leukemia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	70 and under	NCI, Pharmaceutical / Industry	RUSH-AML-9754 ALZA-RUSH-AML-9754, NCI-V98-1445, NCT00003405

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.

Entry 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

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Rush Cancer Institute at Rush University Medical Center

Philip Bonomi, MD, Protocol chair		Ph: 312-942-8312 Email: Philip_Bonomi@rsh.net

Registry Information
Official Title		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
Trial Start Date		1998-04-01
Registered in ClinicalTrials.gov		NCT00003405
Date Submitted to PDQ		1998-06-30
Information Last Verified		2001-02-01
NCI Grant/Contract Number		P01-CA75606

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