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High Dose Chemotherapy, Peripheral Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Acute Myeloid Leukemia
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Roswell Park Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002945
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill leukemia cells.

PURPOSE: Phase III trial to study the effectiveness of high-dose combination chemotherapy, peripheral stem cell transplantation, and interleukin-2 in treating patients who have acute myeloid leukemia.


Condition Intervention Phase
Leukemia
 Biological: aldesleukin
Biological: filgrastim
Drug: cyclophosphamide
Drug: cytarabine
Drug: etoposide
Drug: idarubicin
Drug: melphalan
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
 Phase III

Study Type: Interventional
Study Design: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Radiation Therapy
Drug Information available for: Cyclophosphamide Cytarabine hydrochloride Etoposide Idarubicin hydrochloride Idarubicin Interleukin-2 Aldesleukin Etoposide phosphate Filgrastim Cytarabine Melphalan
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 100
Study Start Date: December 1996
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002945

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
Study Chair: Maria R. Baer, MD Roswell Park Cancer Institute
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: CDR0000065406, RPCI-DS-96-48, NCI-G97-1152
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00002945     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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)

Study placed in the following topic categories:
Antimetabolites
Leukemia, Monocytic, Acute
Anti-Infective Agents
Melphalan
Immunologic Factors
Acute Myelomonocytic Leukemia
Acute Monoblastic Leukemia
Cyclophosphamide
Leukemia, Myeloid, Acute
Etoposide phosphate
Anti-Bacterial Agents
Leukemia
Acute Erythroblastic Leukemia
Acute Myelocytic Leukemia
Anti-Retroviral Agents
 Acute Myeloid Leukemia, Adult
Neoplasm Metastasis
Analgesics
Alkylating Agents
Etoposide
Cytarabine
Anti-HIV Agents
Leukemia, Myeloid
Antiviral Agents
Immunosuppressive Agents
Leukemia, Myelomonocytic, Acute
Idarubicin
Leukemia, Erythroblastic, Acute
Aldesleukin
Analgesics, Non-Narcotic

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Cyclophosphamide
Antibiotics, Antineoplastic
Leukemia, Myeloid, Acute
Leukemia
Anti-Retroviral Agents
Sensory System Agents
Therapeutic Uses
Analgesics
 Etoposide
Alkylating Agents
Cytarabine
Anti-HIV Agents
Neoplasms by Histologic Type
Leukemia, Myeloid
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Idarubicin
Neoplasms
Aldesleukin
Analgesics, Non-Narcotic
Interleukin-2
Myeloablative Agonists

ClinicalTrials.gov processed this record on September 02, 2009



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