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High-Dose Cytarabine and Idarubicin Induction, High Dose Etoposide and Cyclophosphamide Intensification, Autologous Stem Cell Transplantation and Interleukin-2 Immune Modulation in Previously Untreated De Novo and Secondary Adult Myeloid Leukemia


Phase 3
25 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

High-Dose Cytarabine and Idarubicin Induction, High Dose Etoposide and Cyclophosphamide Intensification, Autologous Stem Cell Transplantation and Interleukin-2 Immune Modulation in Previously Untreated De Novo and Secondary Adult Myeloid Leukemia


OBJECTIVES:

- Determine relapse free survival of patients with previously untreated de novo or
secondary acute myeloid leukemia treated with high dose cytarabine and idarubicin
induction, high dose etoposide and cyclophosphamide intensification, filgrastim
(G-CSF), melphalan, radiotherapy, autologous peripheral blood stem cell (PBSC)
transplantation, and interleukin-2.

- Correlate remission rate and relapse free survival with multidrug resistance phenotype
in patients treated with this regimen.

- Determine stem cell content and presence of cells with leukemia specific markers in
PBSC harvested following high dose etoposide and cyclophosphamide intensification.

- Correlate NK cell expansion (an increase in both proportion and absolute number) during
interleukin-2 therapy following autologous PBSC transplantation with disease free
survival.

OUTLINE:

Induction

- Patients receive cytarabine IV over 1 hour every 12 hours for 6 days and idarubicin IV
over 30 minutes following third, fifth, and seventh doses of cytarabine. Beginning 12
hours after the last dose of cytarabine, patients receive filgrastim (G-CSF)
subcutaneously (SQ) each day until blood counts recover.

Intensification

- Patients receive etoposide IV over 34.3 hours followed 1 hour later by cyclophosphamide
IV over 2 hours for 3 days. Beginning 24 hours after the last dose of cyclophosphamide,
patients receive G-CSF SQ each day until blood counts recover.

Peripheral blood stem cells (PBSC) are harvested and selected for CD34+ cells. Patients
receive melphalan IV over 1 hour on day -4 followed by total body irradiation on days -3,
-2, and -1. PBSC are reinfused on day 0.

When blood counts recover, patients receive high dose interleukin-2 SQ on days 1-10 followed
by low dose interleukin-2 SQ on days 11-13. Interleukin-2 treatment repeats every 14 days
for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with
immunologic response to 6 courses of interleukin-2 treatment may continue for 6 additional
courses.

PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study over 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven de novo or secondary acute myeloid leukemia with a
classification of M0-M2 or M4-M7

- No classification of M3

- No promyelocytic leukemia

- Prior medical conditions allowed:

- Myelodysplastic syndromes

- Aplastic anemia

- Paroxysmal nocturnal hemoglobinuria

- Myeloproliferative disorders except Philadelphia chromosome positive chronic
myelogenous leukemia

PATIENT CHARACTERISTICS:

Age:

- Over 25

Performance status:

- Not specified

Life expectancy:

- At least 4 weeks

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin no greater than 2 times normal

- SGOT no greater than 2 times normal

- Alkaline phosphatase no greater than 2 times normal

Renal:

- Creatinine no greater than 1.5 times normal

Cardiovascular:

- Ejection fraction at least 45%

- No severe cardiovascular disease including myocardial infarction within past 6
months, uncontrolled symptomatic congestive heart failure, angina pectoris, or
multifocal cardiac arrhythmias

Other:

- No uncontrolled diabetes mellitus

- No other active malignancy

- No hypersensitivity to E. coli derived drug preparations

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for acute leukemia except hydroxyurea

- Prior chemotherapy allowed for other malignancy or other medical condition

Endocrine therapy:

- Not specified

Radiotherapy:

- Prior radiotherapy allowed for other malignancy or other medical condition

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the efficacy of 4-6 h and 18-24 h, 20% ALA applications on superficial and nodular epidermally-derived lesions using ca633 nm laser irradiation.

Outcome Description:

To determine the efficacy of 4-6 h and 18-24 h, 20% ALA applications on superficial and nodular epidermally-derived lesions using ca633 nm laser irradiation.

Outcome Time Frame:

24 hours

Safety Issue:

Yes

Principal Investigator

Meir Wetzler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000065406

NCT ID:

NCT00002945

Start Date:

December 1996

Completion Date:

August 2011

Related Keywords:

  • Leukemia
  • untreated adult acute myeloid leukemia
  • adult acute monoblastic leukemia and acute monocytic leukemia (M5)
  • adult acute erythroid leukemia (M6)
  • adult acute myeloblastic leukemia without maturation (M1)
  • adult acute myeloblastic leukemia with maturation (M2)
  • adult acute myelomonocytic leukemia (M4)
  • adult acute megakaryoblastic leukemia (M7)
  • secondary acute myeloid leukemia
  • adult acute minimally differentiated myeloid leukemia (M0)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263