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

Leukemia Clinical Trial

Official title:

Autologous Bone Marrow Transplantation for Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome - A Phase II Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004899
• Other study ID #: NU 91H1T
• Secondary ID: NU-91H1TNCI-G00-
• Status: Completed
• Phase: Phase 2
• First received: March 7, 2000
• Last updated: June 8, 2012
• Start date: October 1999
• Est. completion date: August 2004

Study information

• Verified date: June 2012
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

• Determine the overall survival and disease free survival of patients with acute myelogenous leukemia or myelodysplastic syndrome treated with busulfan and etoposide followed by autologous bone marrow transplantation and filgrastim (G-CSF).

• Assess the toxicities of this regimen in this patient population.

• Assess the hematologic effects and toxicities of G-CSF given in this setting to these patients.

• Determine whether G-CSF stimulates leukemic relapse in these patients.

• Determine whether G-CSF has an affect on platelet recovery in this setting in these patients.

OUTLINE: Patients are stratified according to first, second, or third remission. Patients undergo bone marrow collection.

Patients receive oral busulfan every 6 hours for 16 doses on days -5, -4, -3, and -2. Patients receive etoposide IV over 4 hours on days -4, -3, and -2. Bone marrow is reinfused 36-48 hours after the last dose of etoposide. Patients receive filgrastim (G-CSF) IV daily beginning 2-4 hours after bone marrow reinfusion until hematopoietic recovery.

Patients are followed monthly for 1 year, every 3 months for 1 year, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 2 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 65 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Diseases
• Myeloproliferative Disorders
• Preleukemia
• Syndrome

Intervention

Biological:
• filgrastim

Drug:
• busulfan

• etoposide

Procedure:
• autologous bone marrow transplantation

Locations

Country	Name	City	State
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,