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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00003407
Recruitment Status : Unknown
Verified May 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : April 27, 2004
Last Update Posted : May 12, 2009
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE April 27, 2004
Last Update Posted Date May 12, 2009
Study Start Date  ICMJE April 1998
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Amifostine and High-Dose Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Chronic Myelogenous Leukemia
Official Title  ICMJE 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
Brief 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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Supportive Care
Condition  ICMJE
  • Drug/Agent Toxicity by Tissue/Organ
  • Leukemia
  • Myelodysplastic Syndromes
  • Neutropenia
Intervention  ICMJE
  • Drug: amifostine trihydrate
  • Drug: cytarabine
  • Drug: mitoxantrone hydrochloride
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April¬†9,¬†2007)
50
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00003407
Other Study ID Numbers  ICMJE CDR0000066416
RUSH-AML-9801
ALZA-RUSH-AML-9801
NCI-V98-1447
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Rush University Medical Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Philip D. Bonomi, MD Rush University Medical Center
PRS Account National Cancer Institute (NCI)
Verification Date May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP