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Home > "I" Clinical Trials Conditions > Interleukin-2 in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia  Interleukin-2 in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia
Interleukin-2 in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia
For Condition: recurrent adult acute myeloid leukemia
Status: No longer recruiting
Sponsor(s): EORTC Leukemia Cooperative Group ,
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/60 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RoelWillemze, Study Chair, EORTC Leukemia Cooperative Group
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
Hotel Dieu de Paris
Paris, , 75181
France
Ospedale San Eugenio
Rome, , 00144
Italy
Institut Jules Bordet
Brussels, , 1000
Belgium
Innsbruck Universitaetsklinik
Innsbruck, , A-6020
Austria
Azienda Policlinico Umberto Primo
Rome, , 00161
Italy
Institut Gustave Roussy
Villejuif, , F-94805
France
University Medical Center Nijmegen
Nijmegen, , NL-6252 HB
Netherlands
University Hospital Rebro
Zagreb, , 41000
Croatia
Leiden University Medical Center
Leiden, , 2300 CA
Netherlands
Additional Information:
Study ID Numbers: CDR0000065933; EORTC-06964
Study Start Date: October 1997
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003148
Other Recurrent Adult Acute Myeloid Leukemia Studies:
1. Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia
2. GTI-2040 and High-Dose Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia
3. Oblimersen and Gemtuzumab Ozogamicin in Treating Older Patients With Relapsed Acute Myeloid Leukemia
4. Dolastatin 10 in Treating Patients With Refractory or Relapsed Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia
5. Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia
Related Studies:
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Interleukin-2 in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia
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