Combination Chemotherapy Plus Biological Therapy in Treating Patients With Acute Myelogenous Leukemia

Leukemia Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00003405
• Other study ID #: CDR0000066413
• Secondary ID: P01CA075606RUSH-
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 1998
• Est. completion date: April 1999

Study information

• Verified date: October 2021
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1999
• Est. primary completion date: April 1999
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Biological:
• recombinant interferon alfa

Drug:
• amifostine trihydrate

• bromodeoxyuridine

• cytarabine

• idarubicin

• idoxuridine

• isotretinoin

• mitoxantrone hydrochloride

Locations

Country	Name	City	State
United States	Angelo P. Creticos, M.D. Cancer Center	Chicago	Illinois
United States	Cook County Hospital	Chicago	Illinois
United States	Rush Cancer Institute	Chicago	Illinois
United States	Rush-Riverside Cancer Center	Kankakee	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,