Chemotherapy Plus Bone Marrow Transplantation and Filgrastim in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

• Status: Completed
• Trial end date: 2004-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing and die. Bone marrow transplantation may be able to replace cells that were destroyed by chemotherapy. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus bone marrow transplantation and filgrastim in treating patients who have acute myelogenous leukemia or myelodysplastic syndrome.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Busulfan; Etoposide; Lenograstim

Criteria

DISEASE CHARACTERISTICS:

• Morphologically proven (from bone marrow aspirate smears or touch preps of marrow biopsy) of myelodysplastic syndrome or acute myelogenous leukemia (AML) of 1 of the following subtypes:

• Acute myeloblastic leukemia (FAB M1 or M2)

• Acute promyelocytic leukemia (FAB M3)

• Acute myelomonocytic leukemia (FAB M4)

• Acute monocytic leukemia (FAB M5)

• Acute erythroleukemia (FAB M6)

• In complete remission at time of marrow or stem cell harvesting

• No relapsed AML unless bone marrow or peripheral blood stem cells previously harvested in remission are available for transplantation

• May have had secondary AML that is either therapy related or that has evolved from an antecedent myelodysplastic syndrome

• History of CNS disease during induction allowed provided inactive and cytologic examination of spinal fluid from preharvest lumbar puncture shows no evidence of leukemia

• No occult or symptomatic leukemic meningitis during induction therapy or prior to bone marrow harvesting

PATIENT CHARACTERISTICS:

Age:

• Physiologic 65 and under

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 2.0 mg/dL

Renal:

• Creatinine no greater than 2.0 mg/dL

• Creatinine clearance at least 50 mL/min

Cardiovascular:

• Cardiac ejection fraction normal

Pulmonary:

• FEV1 at least 60% predicted

• DLCO at least 60% predicted

Other:

• HIV negative

• No evidence of persistent infections

• No concurrent organ damage or medical problems that would preclude study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No concurrent antibiotics