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| Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004899 |
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 II |
| Study Type: | Interventional |
| Study Design: | 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 |
| Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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
| Study ID Numbers: | CDR0000067578, NU-91H1T, NCI-G00-1688 |
| Study First Received: | March 7, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004899 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia adult acute myeloid leukemia in remission childhood acute myeloid leukemia in remission adult acute erythroid leukemia (M6) 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) childhood acute erythroleukemia (M6) 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 |
|
Leukemia, Monocytic, Acute Precancerous Conditions Acute Myelomonocytic Leukemia Acute Monoblastic Leukemia Leukemia, Myeloid, Acute Etoposide phosphate Leukemia Preleukemia Acute Myelocytic Leukemia Acute Erythroblastic Leukemia Acute Myeloid Leukemia, Adult Leukemia, Promyelocytic, Acute Neoplasm Metastasis Congenital Abnormalities Etoposide |
Myelodysplastic Myeloproliferative Disease Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Myelodysplastic Syndromes Myeloproliferative Disorders Leukemia, Myeloid Recurrence Leukemia, Myelomonocytic, Acute Acute Myeloid Leukemia, Childhood Leukemia, Erythroblastic, Acute Busulfan Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chronic Myelogenous Leukemia Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases |
|
Disease Neoplasms by Histologic Type Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Leukemia, Myeloid Leukemia, Myeloid, Acute |
Leukemia Preleukemia Neoplasms Pathologic Processes Syndrome Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases |
