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Interleukin-2 in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia

This study is ongoing, but not recruiting participants.

Sponsored by: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003148
  Purpose

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill acute myelogenous leukemia cells.

PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients with acute myelogenous leukemia that has relapsed following previous treatment.


Condition Intervention Phase
Leukemia
Drug: aldesleukin
Phase II

MedlinePlus related topics:   Leukemia, Adult Acute    Leukemia, Adult Chronic   

Drug Information available for:   Aldesleukin    Interleukin-2   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase II Study of the Efficacy of rH Interleukin-2 in Patients With Slowly Progressing Acute Myelogenous Leukemia (AML) and With Limited Bone Marrow Blastosis After Autologous Stem Cell Transplantation or Chemotherapy

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

Estimated Enrollment:   86
Study Start Date:   October 1997

Detailed Description:

OBJECTIVES: I. Assess the therapeutic activity of interleukin-2 (IL-2) in patients with slowly progressing acute myeloid leukemia with limited bone marrow blastosis either in first relapse after autologous bone marrow or peripheral blood stem cell transplantation, or with more advanced disease (i.e., refractory to chemotherapy regimens). II. Characterize the acute side effects of IL-2 in these patients.

OUTLINE: This is an open label, nonrandomized, multicenter study. Patients are stratified into two categories of prior failed treatments (first relapse after autologous bone marrow or peripheral blood stem cell transplantation vs first or subsequent relapse either refractory to or not eligible for further conventional treatment). Interleukin-2 (IL-2) is administered as a continuous intravenous infusion on 5 consecutive days at daily escalating doses for the first cycle. When the individual maximum tolerated dose (MTD) has been determined, 3 more cycles are given at the MTD. There are 3 days of rest between each treatment cycle. After the induction phase, maintenance cycles of IL-2 are administered starting 4 weeks after the last induction treatment. Maintenance cycles of IL-2 are administered subcutaneously on 5 consecutive days every 4 weeks for 2 years, and subsequently every other month for a maximum of 3 years. Treatment continues until disease progression or unacceptable toxicity for a maximum of 5 years. Patients are followed every 4 weeks during the first 2 years, then every 8 weeks during the next 3 years or until documented progression, and then every 3 months until death.

PROJECTED ACCRUAL: A maximum of 86 (57 transplanted; 29 patients nontransplanted) patients will be accrued into this study within 2 years.

  Eligibility
Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed acute myeloid leukemia (AML) that has relapsed after prior treatment(s) Slowly progressing disease as defined by bone marrow blasts of greater than 5% and less than 30% confirmed by at least 2 marrow aspirates taken 2 weeks apart Must be in either: First relapse after autologous bone marrow or peripheral blood stem cell transplantation OR First or subsequent relapse either refractory to or not eligible for further conventional treatment regimens

PATIENT CHARACTERISTICS: Age: 18 to 60 Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Bilirubin less than 2 times normal Renal: Creatinine less than 2 times normal Cardiovascular: Ejection fraction normal Pulmonary: PLCO diffusion greater than 60% Other: No active uncontrolled infections No other progressive malignant disease Not a poor medical risk because of nonmalignant systemic disease

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics Endocrine therapy: No concurrent steroids Radiotherapy: Not specified Surgery: Not specified Other: No concurrent indomethacin No other concurrent anticancer or investigational therapy

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003148

Locations
Austria
Innsbruck Universitaetsklinik    
      Innsbruck, Austria, A-6020
Belgium
Institut Jules Bordet    
      Brussels, Belgium, 1000
Universitair Ziekenhuis Antwerpen    
      Edegem, Belgium, B-2650
Croatia
University Hospital Rebro    
      Zagreb, Croatia, 41000
France
Hotel Dieu de Paris    
      Paris, France, 75181
Institut Gustave Roussy    
      Villejuif, France, F-94805
Italy
Azienda Policlinico Umberto Primo    
      Rome, Italy, 00161
Ospedale San Eugenio    
      Rome, Italy, 00144
Netherlands
Leiden University Medical Center    
      Leiden, Netherlands, 2300 CA
University Medical Center Nijmegen    
      Nijmegen, Netherlands, NL-6252 HB

Sponsors and Collaborators
European Organization for Research and Treatment of Cancer

Investigators
Study Chair:     Roel Willemze, MD, PhD     Leiden University Medical Center    
  More Information


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

Study ID Numbers:   CDR0000065933, EORTC-06964
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003148
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult acute myeloid leukemia  

Study placed in the following topic categories:
Leukemia
Aldesleukin
Interleukin-2
Acute myelogenous leukemia
Acute myeloid leukemia, adult
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Acute myelocytic leukemia
Recurrence

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms by Histologic Type
Anti-HIV Agents
Antineoplastic Agents
Physiological Effects of Drugs
Antiviral Agents
Pharmacologic Actions
Neoplasms
Anti-Retroviral Agents
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on December 02, 2008




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