Amifostine and High-Dose Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Chronic Myelogenous Leukemia
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| ClinicalTrials.gov Identifier: NCT00003407 |
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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
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Drug/Agent Toxicity by Tissue/Organ Leukemia Myelodysplastic Syndromes Neutropenia | Drug: amifostine trihydrate Drug: cytarabine Drug: mitoxantrone hydrochloride | Phase 2 |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| 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 |
| Study Start Date : | April 1998 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003407
| United States, Illinois | |
| Cook County Hospital | |
| Chicago, Illinois, United States, 60612-9985 | |
| Rush Cancer Institute | |
| Chicago, Illinois, United States, 60612 | |
| Angelo P. Creticos, M.D. Cancer Center | |
| Chicago, Illinois, United States, 60657 | |
| Rush-Riverside Cancer Center | |
| Kankakee, Illinois, United States, 60901 | |
| Study Chair: | Philip D. Bonomi, MD | Rush University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00003407 |
| Other Study ID Numbers: |
CDR0000066416 RUSH-AML-9801 ALZA-RUSH-AML-9801 NCI-V98-1447 |
| First Posted: | April 27, 2004 Key Record Dates |
| Last Update Posted: | May 12, 2009 |
| Last Verified: | May 2006 |
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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 |
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Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Preleukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Myelodysplastic Syndromes Neutropenia Syndrome Drug-Related Side Effects and Adverse Reactions Disease Pathologic Processes Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases |
Precancerous Conditions Myeloproliferative Disorders Agranulocytosis Leukopenia Leukocyte Disorders Chemically-Induced Disorders Cytarabine Mitoxantrone Amifostine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents |