Combination Chemotherapy Plus Biological Therapy in Treating Patients With Acute Myelogenous Leukemia
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia
Intervention: amifostine trihydrate (Drug); bromodeoxyuridine (Drug); cytarabine (Drug); idarubicin (Drug); idoxuridine (Drug); isotretinoin (Drug); mitoxantrone hydrochloride (Drug); recombinant interferon alfa (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Rush University Medical Center
Official(s) and/or principal investigator(s):
Philip D. Bonomi, MD, Study Chair, Affiliation: Rush University Medical Center
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.
Official title: 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
Study design: Treatment
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.
Minimum age: N/A.
Maximum age: 70 Years.
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
Locations and Contacts
Angelo P. Creticos, M.D. Cancer Center, Chicago, Illinois 60657, United States
Cook County Hospital, Chicago, Illinois 60612-9985, United States
Rush Cancer Institute, Chicago, Illinois 60612, United States
Rush-Riverside Cancer Center, Kankakee, Illinois 60901, United States
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: April 1998
Last updated: May 23, 2008