Chemotherapy Plus Bone Marrow Transplantation and Filgrastim in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Biological: filgrastim Drug: busulfan Drug: etoposide Procedure: autologous bone marrow transplantation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Autologous Bone Marrow Transplantation for Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome - A Phase II Pilot Study |
| Study Start Date: | October 1999 |
| Study Completion Date: | August 2004 |
| Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | up to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| Study Chair: | Martin S. Tallman, MD | Robert H. Lurie Cancer Center |
More Information
No publications provided
| Responsible Party: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00004899 History of Changes |
| Other Study ID Numbers: | NU 91H1T, NU-91H1T, NCI-G00-1688 |
| Study First Received: | March 7, 2000 |
| Last Updated: | June 8, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Northwestern University:
|
adult acute erythroid leukemia (M6) childhood acute erythroleukemia (M6) recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia adult acute myeloid leukemia in remission childhood acute myeloid leukemia in remission adult acute myeloblastic leukemia without maturation (M1) adult acute myeloblastic leukemia with maturation (M2) adult acute promyelocytic leukemia (M3) adult acute myelomonocytic leukemia (M4) adult acute monoblastic leukemia (M5a) childhood acute myeloblastic leukemia without maturation (M1) childhood acute myeloblastic leukemia with maturation (M2) childhood acute promyelocytic leukemia (M3) |
childhood acute myelomonocytic leukemia (M4) childhood acute monoblastic leukemia (M5a) childhood acute monocytic leukemia (M5b) secondary acute myeloid leukemia adult acute monocytic leukemia (M5b) previously treated myelodysplastic syndromes myelodysplastic/myeloproliferative disease, unclassifiable atypical chronic myeloid leukemia adult acute myeloid leukemia with t(8;21)(q22;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with t(15;17)(q22;q12) childhood myelodysplastic syndromes |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Myelodysplastic-Myeloproliferative Diseases Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Busulfan Etoposide |
Lenograstim Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Phytogenic Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on May 16, 2013