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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003407
First received: November 1, 1999
Last updated: May 9, 2009
Last verified: May 2006
  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
Drug/Agent Toxicity by Tissue/Organ
Leukemia
Myelodysplastic Syndromes
Neutropenia
Drug: amifostine trihydrate
Drug: cytarabine
Drug: mitoxantrone hydrochloride
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: 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

Resource links provided by NLM:


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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003407     History of Changes
Other Study ID Numbers: CDR0000066416, RUSH-AML-9801, ALZA-RUSH-AML-9801, NCI-V98-1447
Study First Received: November 1, 1999
Last Updated: May 9, 2009
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

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Myelodysplastic Syndromes
Preleukemia
Neutropenia
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Agranulocytosis
Leukopenia
Leukocyte Disorders
Cytarabine
Mitoxantrone
Amifostine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014