Amifostine and High-Dose Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Chronic Myelogenous Leukemia
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Drug/Agent Toxicity by Tissue/Organ; Leukemia; Myelodysplastic Syndromes; Neutropenia
Intervention: amifostine trihydrate (Drug); cytarabine (Drug); mitoxantrone hydrochloride (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Rush University Medical Center Official(s) and/or principal investigator(s):
Philip D. Bonomi, MD, Study Chair, Affiliation: Rush University Medical Center
Summary
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.
Clinical Details
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
Study design: Supportive Care
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
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
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: April 1998
Last updated: June 17, 2008
|
