Brief Title
Busulfan and Etoposide Followed by Peripheral Blood Stem Cell Transplant and Low-Dose Aldesleukin in Treating Patients With Acute Myeloid Leukemia
Official Title
Treatment of Acute Myelogenous Leukemia With Busulfan and Etoposide Followed by Autologous or Syngeneic Stem Cell Rescue and Low-Dose Interleukin 2 (IL-2) Immunotherapy
Brief Summary
This phase II trial studies the side effects and how well giving busulfan and etoposide
followed by peripheral blood stem cell transplant (PBSCT) and low-dose aldesleukin works in
treating patients with acute myeloid leukemia (AML). Drugs used in chemotherapy, such as
busulfan and etoposide, work in different ways to stop the growth of cancer cells, either by
killing the cells or by stopping them from dividing. A PBSCT may be able to replace
blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to
be given so that more cancer cells are killed. Aldesleukin may stimulate the white blood
cells to kill cancer cells. Giving busulfan and etoposide together followed by PBSCT and
aldesleukin may be an effective treatment for AML.
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate the toxicity and overall survival of high dose Bu (busulfan)/VP-16 (etoposide)
followed by post-transplant low-dose interleukin (IL)-2 (aldesleukin) in patients with AML.
SECONDARY OBJECTIVES:
I. To estimate the rate of relapse associated with this regimen.
OUTLINE:
PREPARATIVE REGIMEN: Patients receive busulfan intravenously (IV) over 2 hours or orally (PO)
every 6 hours on days -7 to -4 and etoposide IV on day -3.
STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.
POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive
low-dose aldesleukin subcutaneously (SC) daily for 12 weeks.
After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 3 years, and then annually thereafter.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Overall Survival of Patients on Busulfan and Etoposide Followed by Stem Cell Rescue and Aldesleukin
Secondary Outcome
Proportion of Patients Who Relapsed Associated With the Regimen
Condition
Adult Acute Myeloid Leukemia in Remission
Intervention
busulfan
Study Arms / Comparison Groups
Treatment (chemo, stem cell rescue, interleukin therapy)
Description: PREPARATIVE REGIMEN: Patients receive busulfan IV over 2 hours or PO every 6 hours on days -7 to -4 and etoposide IV on day -3. STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0. POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin SC daily for 12 weeks.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
30
Start Date
October 13, 1998
Completion Date
June 11, 2015
Primary Completion Date
June 11, 2015
Eligibility Criteria
Inclusion Criteria:
- The patient must have AML that falls into one of the following categories:
- AML in 1st complete remission (CR) with intermediate or high risk of relapse following
conventional therapy; at least, one of the following features is needed:
- Patient required more than one cycle of induction to achieve first CR
- White blood cell count (WBC) > 100,000/mm^3 at diagnosis
- Any of the following cytogenetic abnormalities: inv (3), t(3:3), del (5q) or -5,
11q23, del(7q) or -7, del (20q) or -20, abnormal 12p, +11 or t8
- Any other abnormalities or combination of abnormalities which would predict
intermediate or high risk of relapse
- AML beyond first CR
- Any patient with an identical twin donor who also meets the criteria above
- Patients with AML in 1st CR should receive at least two cycles of consolidation
chemotherapy prior to mobilization and transplant
- Patients must have an adequate number of stem cells previously collected (i.e., > 2 x
10^8 total nucleated cell [TNC] of bone marrow [BM]/kg or 4 x 10^6 [CD]34+ PBSC/kg,
unless approved otherwise by Dr. Holmberg); prior to stem cell collection patients
must be documented to be in remission and to have received two cycles of consolidation
therapy after induction therapy
- Pre-Study tests have been performed
- Patient must sign an institutional review board (IRB) approved informed consent,
conforming with federal and institutional guidelines
Exclusion Criteria:
- Patients with good risk AML defined by cytogenetic evaluation with these
abnormalities: inversion 16 or t8;21
- Patient's life expectancy is severely limited by diseases other than AML
- Patient is human immunodeficiency virus (HIV) seropositive
- Patient is pregnant
- Patient's creatinine > 2.0 mg/dl
- Patient's total bilirubin > 2.0 mg/dl (unless Gilbert's disease)
- Or serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvic transaminase
(SGPT) >= 2.5 x upper limit of normal (ULN) not due to leukemia
- Patient has a history of congestive heart failure, uncontrolled arrhythmias or left
ventricular ejection fraction (LVEF) < 50%
- Patient has an unrelated human leukocyte antigen (HLA) matched donor and is eligible
for a higher priority Fred Hutchinson Cancer Research Center (FHCRC) protocol (for
FHCRC patients only)
- Patient has an HLA matched or one antigen mismatch family donor available
- Patients with a significant active infection that precludes transplant
- Patients with a Karnofsky Performance Score less than 70
Gender
All
Ages
N/A - 65 Years
Accepts Healthy Volunteers
No
Contacts
Leona Holmberg, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00003875
Organization ID
1315.00
Secondary IDs
NCI-2011-00439
Responsible Party
Principal Investigator
Study Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Leona Holmberg, Principal Investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Verification Date
May 2017