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

Alternate Title

Amifostine and High-Dose Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Chronic Myelogenous Leukemia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Supportive care, Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	RUSH-AML-9801 ALZA-RUSH-AML-9801, NCI-V98-1447, NCT00003407

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.

Entry 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

Prior/Concurrent Therapy:

See Disease Characteristics

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

Expected Enrollment

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

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.

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		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
Trial Start Date		1998-04-01
Registered in ClinicalTrials.gov		NCT00003407
Date Submitted to PDQ		1998-06-30
Information Last Verified		2006-05-22
NCI Grant/Contract Number		P01-CA75606

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