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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2001 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003405
First received: November 1, 1999
Last updated: February 6, 2009
Last verified: February 2001
  Purpose

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.


Condition Intervention Phase
Leukemia
Biological: recombinant interferon alfa
Drug: amifostine trihydrate
Drug: bromodeoxyuridine
Drug: cytarabine
Drug: idarubicin
Drug: idoxuridine
Drug: isotretinoin
Drug: mitoxantrone hydrochloride
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 45
Study Start Date: April 1998
Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003405

Locations
United States, Illinois
Angelo P. Creticos, M.D. Cancer Center
Chicago, Illinois, United States, 60657
Cook County Hospital
Chicago, Illinois, United States, 60612-9985
Rush Cancer Institute
Chicago, Illinois, United States, 60612
Rush-Riverside Cancer Center
Kankakee, Illinois, United States, 60901
Sponsors and Collaborators
Rush University Medical Center
Investigators
Study Chair: Philip D. Bonomi, MD Rush University Medical Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003405     History of Changes
Other Study ID Numbers: CDR0000066413, RUSH-AML-9754, ALZA-RUSH-AML-9754, NCI-V98-1445
Study First Received: November 1, 1999
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult acute erythroid leukemia (M6)
childhood acute erythroleukemia (M6)
untreated adult acute myeloid leukemia
untreated childhood acute myeloid leukemia and other myeloid malignancies
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 megakaryocytic leukemia (M7)
adult acute monocytic leukemia (M5b)

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Interferon-alpha
Bromodeoxyuridine
Cytarabine
Idoxuridine
Interferons
Idarubicin
Mitoxantrone
Amifostine
Isotretinoin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Radiation-Sensitizing Agents
Immunosuppressive Agents
Radiation-Protective Agents
Protective Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors

ClinicalTrials.gov processed this record on September 14, 2014