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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Rush University Medical Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003407
  Purpose

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 Intervention Phase
Cancer-Related Problem/Condition
Leukemia
Myelodysplastic Syndromes
Drug: amifostine trihydrate
Drug: cytarabine
Drug: mitoxantrone hydrochloride
Phase II

MedlinePlus related topics:   Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic   

Drug Information available for:   Cytarabine    Cytarabine hydrochloride    Dexamethasone    Dexamethasone acetate    Dexamethasone Sodium Phosphate    Doxiproct plus    Mitoxantrone hydrochloride    Mitoxantrone    Pentoxifylline    Pentoxyl    Ciprofloxacin    Ciprofloxacin hydrochloride    Amifostine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care
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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   50
Study Start Date:   April 1998

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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003407

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

Sponsors and Collaborators
Rush University Medical Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Philip D. Bonomi, MD     Rush University Medical Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000066416, RUSH-AML-9801, ALZA-RUSH-AML-9801, NCI-V98-1447
First Received:   November 1, 1999
Last Updated:   October 18, 2008
ClinicalTrials.gov Identifier:   NCT00003407
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult acute myeloid leukemia  
blastic phase chronic myelogenous leukemia  
untreated adult acute myeloid leukemia  
refractory anemia with excess blasts in transformation  
secondary acute myeloid leukemia  
de novo myelodysplastic syndromes
secondary myelodysplastic syndromes
drug/agent toxicity by tissue/organ
neutropenia

Study placed in the following topic categories:
Dexamethasone
Blast Crisis
Precancerous Conditions
Chronic myelogenous leukemia
Refractory anemia
Leukemia, Myeloid, Acute
Pentoxifylline
Ciprofloxacin
Leukemia
Preleukemia
Anemia, Refractory
Neoplasm Metastasis
Acute myeloid leukemia, adult
Acute myelocytic leukemia
Dexamethasone acetate
Cytarabine
Myelodysplastic syndromes
Amifostine
Hematologic Diseases
Myelodysplastic Syndromes
Myelodysplasia
Anemia
Myeloproliferative Disorders
Acute myelogenous leukemia
Leukemia, Myeloid
Recurrence
Neutropenia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Mitoxantrone
Anemia, Refractory, with Excess of Blasts

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Radiation-Protective Agents
Neoplasms by Histologic Type
Disease
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Protective Agents
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Pathologic Processes
Sensory System Agents
Syndrome
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2008




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