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

NCT00003405 | Withdrawn Phase 2

• 5 other identifiers: CDR0000066413P01CA075606RUSH-AML-9754ALZA-RUSH-AML-9754NCI-V98-1445
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Leukemia

Keywords

untreated adult acute myeloid leukemia; untreated childhood acute myeloid leukemia and other myeloid malignancies; adult acute erythroid leukemia (M6); adult acute myeloblastic leukemia without maturation (M1); adult acute myeloblastic leukemia with maturation (M2); adult acute myelomonocytic leukemia (M4); adult acute monoblastic leukemia (M5a); adult acute megakaryoblastic leukemia (M7); childhood acute myeloblastic leukemia without maturation (M1); childhood acute myeloblastic leukemia with maturation (M2); childhood acute myelomonocytic leukemia (M4); childhood acute monoblastic leukemia (M5a); childhood acute monocytic leukemia (M5b); childhood acute erythroleukemia (M6); childhood acute megakaryocytic leukemia (M7); adult acute monocytic leukemia (M5b)

Interventions

recombinant interferon alfa BIOLOGICAL

amifostine trihydrate DRUG

bromodeoxyuridine DRUG

cytarabine DRUG

idarubicin DRUG

idoxuridine DRUG

isotretinoin DRUG

mitoxantrone hydrochloride DRUG

Eligibility Criteria

• Age: 0 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Rush University Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Cook County Hospital

Chicago, Illinois, 60612-9985, United States

Location

Rush Cancer Institute

Chicago, Illinois, 60612, United States

Location

Angelo P. Creticos, M.D. Cancer Center

Chicago, Illinois, 60657, United States

Location

Rush-Riverside Cancer Center

Kankakee, Illinois, 60901, United States

Location

MeSH Terms

Conditions

Leukemia; Leukemia, Erythroblastic, Acute; Leukemia, Myeloid, Acute; Leukemia, Myelomonocytic, Acute; Leukemia, Monocytic, Acute; Leukemia, Megakaryoblastic, Acute

Interventions

Interferon-alpha; Amifostine; Bromodeoxyuridine; Cytarabine; Idarubicin; Idoxuridine; Isotretinoin; Mitoxantrone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Organothiophosphates; Organophosphates; Organophosphorus Compounds; Organic Chemicals; Organothiophosphorus Compounds; Sulfur Compounds; Deoxyuridine; Uridine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Cytidine; Arabinonucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Terpenes; Pigments, Biological; Anthraquinones; Anthrones; Anthracenes; Quinones

Study Officials

• Philip D. Bonomi, MD

  Rush University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 24, 2004
• Study Start: April 1, 1998
• Primary Completion: April 1, 1999
• Study Completion: April 1, 1999
• Last Updated: October 14, 2021

Record last verified: 2021-10

Locations

US (4)