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Combination Chemotherapy Plus Biological Therapy in Treating Patients With Acute Myelogenous Leukemia
This study is ongoing, but not recruiting participants.
Study NCT00003405   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes

November 1, 1999
February 6, 2009
April 1998
 
 
 
Complete list of historical versions of study NCT00003405 on ClinicalTrials.gov Archive Site
 
 
 
Combination Chemotherapy Plus Biological Therapy in Treating Patients With Acute Myelogenous Leukemia
Treatment Protocol for Patients With Standard Risk Acute Myelogenous Leukemia and Its Variants: Induction Using High-Dose Cytarabine, Mitoxantrone and Ethyol; Consolidation With Cytarabine and Idarubicin and Maintenance With 13 Cis Retinoic Acid and Alpha Interferon

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cell from growing. Combining more than one chemotherapy drug with biological therapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, isotretinoin, and interferon alfa in treating patients who have acute myelogenous leukemia.

OBJECTIVES: I. Assess the efficacy of high dose cytarabine with mitoxantrone and amifostine as induction therapy for patients with previously untreated standard risk acute myelogenous leukemia (AML). II. Assess the effects of amifostine on the biology of AML cells in vivo in these patients. III. Determine whether there is a relationship between cytokine production before and during remission induction therapy and treatment outcome.

OUTLINE: Prior to treatment, patients undergo bone marrow aspirate and biopsy. On day -3, patients receive idoxuridine IV over 60 minutes followed immediately by a bone marrow aspirate and biopsy. Patients then receive amifostine IV over 5-7 minutes on the same day. Prior to chemotherapy on day 1, patient receive broxuridine IV over 60 minutes immediately followed by bone marrow aspirate and biopsy. Chemotherapy on day 1 consists of amifostine followed by cytarabine IV over 3 hours repeated every 12 hours and mitoxantrone IV over 1 hour immediately after the second infusion of cytarabine. This course is repeated on day 5 after another bone marrow biopsy and aspirate. Starting on day 6, patients receive amifostine 3 times a week until day 28 or beyond. Patients who respond to treatment continue on to receive three courses of consolidation therapy. Consolidation courses 1 and 3 consist of cytarabine continuous IV on days 1-7 and idarubicin IV over 30 minutes on days 1, 2, and 3. Consolidation course 2 consists of cytarabine IV over 75 minutes repeated every 12 hours for 4 days. Twenty-four hours after each course of consolidation therapy, patients receive isotretinoin orally every day and interferon alfa subcutaneously every other day. Isotretinoin and interferon alfa therapy are stopped 4 days prior to day 1 of the next course of consolidation therapy. Following recovery from course 3 of consolidation therapy, patients continue to receive isotretinoin/interferon alfa until relapse. Patients in complete remission after the 3 courses of consolidation therapy receive isotretinoin/interferon alfa for 3 years. Patients are followed every 3 months for the first year, then every 6 months for the next 2 years.

PROJECTED ACCRUAL: There will be 40-45 patients accrued into this study.

Phase II
Interventional
Primary Purpose:  Treatment
Leukemia
  • Biological: recombinant interferon alfa
  • Drug: amifostine trihydrate
  • Drug: bromodeoxyuridine
  • Drug: cytarabine
  • Drug: idarubicin
  • Drug: idoxuridine
  • Drug: isotretinoin
  • Drug: mitoxantrone hydrochloride
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
45
 
 

DISEASE CHARACTERISTICS: Histologically confirmed previously untreated acute myelogenous leukemia (AML) FAB M1, M2, M4, M5, M6, or M7 No AML secondary to chemotherapy, radiation therapy, or toxic agents No history of myelodysplastic syndromes If possible, patient should be enrolled on protocol RUSH-CYL-9003

PATIENT CHARACTERISTICS: Age: 70 and under Performance status: 0-3 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin greater than 2.0 mg/dL and no greater than 3.0 mg/dL allowed with 50% reduction in drug doses Renal: Creatinine less than 3.0 mg/dL Cardiovascular: No overt congestive heart failure No uncontrollable ventricular arrhythmias No uncontrollable hypertension If cardiac ejection fraction is less than 45% of predicted, an echocardiogram and a cardiac consult must be obtained to ascertain cardiac tolerance of anthracycline therapy Neurological: No cerebellar dysfunction Other: Fever, infection, or other complications of disease allowed Not pregnant or nursing Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior interferon At least 2 weeks since prior hematopoietic growth factors (including erythropoietin) Chemotherapy: At least 2 weeks since prior chemotherapy Endocrine therapy: At least 2 weeks since prior steroids Radiotherapy: Not specified Surgery: Not specified Other: At least 2 weeks since prior retinoids

Both
up to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003405
 
CDR0000066413, RUSH-AML-9754, ALZA-RUSH-AML-9754, NCI-V98-1445
Rush University Medical Center
National Cancer Institute (NCI)
Study Chair: Philip D. Bonomi, MD Rush University Medical Center
National Cancer Institute (NCI)
February 2001

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