Busulfan and Etoposide Followed by Peripheral Blood Stem Cell Transplant and Low-Dose Aldesleukin in Treating Patients With Acute Myeloid Leukemia

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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 Research 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