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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphocytic Leukemia  Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphocytic Leukemia
Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphocytic Leukemia
For Condition: recurrent adult acute lymphoblastic leukemia
Status: No longer recruiting
Sponsor(s): Medizinische Hochschule Hannover ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have relapsed or refractory acute lymphocytic leukemia.
Details: OBJECTIVES: I. Determine the toxic effects and feasibility of high-dose cytarabine and idarubicin in patients with refractory or relapsed acute lymphocytic leukemia (ALL) after a complete remission (CR) of less than 18 months. II. Determine the response of patients with ALL in first relapse after a CR of 18 months or more treated with a 2-phase re-induction regimen comprising prednisolone, vindesine, daunorubicin, asparaginase, intrathecal (IT) cytarabine, IT dexamethasone, and IT methotrexate followed by prednisolone, ifosfamide, high-dose methotrexate, leucovorin calcium, etoposide, and cytarabine (with a dose-escalation study of etoposide and cytarabine). III. Compare the effectiveness of these 2 regimens administered to these patients with the regimen administered to historic controls (protocol GER-ALL-REZ- 01/88). PROTOCOL OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified by center, duration of complete remission (CR) (less than 18 months vs 18 months or more), and refractory disease (yes vs no). Patients with refractory or relapsed disease after a CR of less than 18 months are treated on Regimen A. Patients in first relapse after a CR of 18 months or more are treated on Regimen B. Regimen A: Patients receive idarubicin IV over 30 minutes followed by cytarabine IV over 3 hours on days 1-3 and filgrastim (G-CSF) subcutaneously (SC) daily beginning on day 5 and continuing until blood counts recover. Regimen B (2-phase reinduction): Patients receive oral prednisolone on days 1-21; vindesine IV and daunorubicin IV on days 1, 8, and 15; asparaginase IV on days 7, 8, 14, and 15; and methotrexate intrathecally (IT), cytarabine IT, and dexamethasone IT on days 1 and 8. When blood counts recover, patients receive oral prednisolone and ifosfamide IV over 1 hour on days 1-4; high-dose methotrexate IV continuously on day 1 followed by standard leucovorin calcium rescue; etoposide IV over 1 hour followed at least 8 hours later by cytarabine IV over 3 hours on days 3 and 4; and G-CSF SC beginning on day 6 and continuing until blood counts recover. Cohorts of 6 patients or more receive escalating doses of etoposide and cytarabine until the maximum tolerated dose is determined. PROJECTED ACCRUAL: Approximately 60 patients (30 per regimen) will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/65 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of refractory or relapsed acute lymphocytic leukemia; No isolated extramedullary relapse (e.g., testicular, CNS); Combined extramedullary and bone marrow relapse allowed - No uncontrolled, severe leukemic complications, e.g.: Pneumonia with hypoxia; Shock; Cardiac failure; Hemorrhage - No refractoriness to platelet transfusion - No unaspirable pleural effusions or ascites in patients with first relapse --Prior/Concurrent Therapy-- - Not specified --Patient Characteristics-- - Age: 15 to 65 - Performance status: Karnofsky 50-100% - Life expectancy: Not specified - Hematopoietic: See Disease Characteristics; No uncontrolled bleeding - Hepatic: No severe liver disease - Renal: Creatinine clearance at least 60 mL/min in patients with first relapse after a complete remission of 18 months or more - Cardiovascular: See Disease Characteristics; No severe cardiac disease (e.g., congestive heart failure, myocardial infarction within the past 6 months, or severe arrhythmia) Pulmonary: See Disease Characteristics; No severe pulmonary disease that would preclude aggressive chemotherapy - Other: No hypersensitivity to E. coli proteins; No severe neurologic or other disease that would preclude aggressive chemotherapy; No severe psychiatric disease or other condition that would preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MathiasFreund, Study Chair, Medizinische Hochschule Hannover
Medizinische Hochschule Hannover
Hannover, , D-30625
Germany
Additional Information:
Study ID Numbers: CDR0000078432; GER-ALL-REZ-02/92,EU-93001
Study Start Date: January 1993
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002532
Other Recurrent Adult Acute Lymphoblastic Leukemia Studies:
1. Dolastatin 10 in Treating Patients With Refractory or Relapsed Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia
2. PS-341 in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia in Blast Phase, or Myelodysplastic Syndrome
3. Arsenic Trioxide in Treating Patients With Recurrent or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia
4. Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia
5. Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia
Related Studies:
Other recurrent adult acute lymphoblastic leukemia Clinical Trials
Other Clinical Trials
Other Hannover Clinical Trials
Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphocytic Leukemia
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