Know Cancer

or
forgot password

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


Phase 2
N/A
65 Years
Open (Enrolling)
Both
Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Childhood Acute Myeloid Leukemia in Remission, Recurrent Adult Acute Myeloid Leukemia, Recurrent Childhood Acute Myeloid Leukemia

Thank you

Trial Information

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


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 high-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.


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 cluster of
differentiation [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 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival of patients on busulfan and etoposide followed by stem cell rescue and aldesleukin

Outcome Description:

Estimated by the method of Kaplan and Meier.

Outcome Time Frame:

At 3 years

Safety Issue:

No

Principal Investigator

Leona Holmberg

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Food and Drug Administration

Study ID:

1315.00

NCT ID:

NCT00003875

Start Date:

November 1998

Completion Date:

Related Keywords:

  • Adult Acute Myeloid Leukemia in Remission
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Del(5q)
  • Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Childhood Acute Myeloid Leukemia in Remission
  • Recurrent Adult Acute Myeloid Leukemia
  • Recurrent Childhood Acute Myeloid Leukemia
  • Congenital Abnormalities
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle, Washington  98109