RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of amifostine and high-dose combination chemotherapy in treating patients with acute myeloid leukemia or chronic myelogenous leukemia.

Condition	Treatment or Intervention	Phase
untreated adult acute myeloid leukemia Drug Toxicity secondary myelodysplastic syndrome recurrent adult acute myeloid leukemia de novo myelodysplastic syndrome refractory anemia with excess blasts in transformation Neutropenia secondary acute myeloid leukemia blastic phase chronic myelogenous leukemia	Drug: amifostine  Drug: cytarabine  Drug: mitoxantrone	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL 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

Illinois
      Angelo P. Creticos, M.D. Cancer Center, Chicago,  Illinois,  60657,  United States
      Cook County Hospital, Chicago,  Illinois,  60612-9985,  United States
      Rush Cancer Institute, Chicago,  Illinois,  60612,  United States
      Rush-Riverside Cancer Center, Kankakee,  Illinois,  60901,  United States

Study chairs or principal investigators

Harvey D. Preisler,  Study Chair,  Rush Cancer Institute at Rush University Medical Center   

Study ID Numbers:  CDR0000066416; RUSH-AML-9801; NCI-V98-1447; ALZA-RUSH-AML-9801
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003407
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08