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Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphocytic Leukemia
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsored by: Hannover Medical School
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002532
  Purpose

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.


Condition Intervention Phase
Leukemia
Biological: filgrastim
Drug: asparaginase
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: etoposide
Drug: idarubicin
Drug: ifosfamide
Drug: leucovorin calcium
Drug: methotrexate
Drug: prednisolone
Drug: vindesine
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: TREATMENT OF ADULT PATIENTS WITH RELAPSING ACUTE LYMPHOCYTIC LEUKEMIA, A MULTICENTER TRIAL

Resource links provided by NLM:


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

Study Start Date: January 1993
Detailed Description:

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).

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

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

PRIOR CONCURRENT THERAPY: Not specified

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002532

Locations
Germany
Medizinische Hochschule Hannover
Hannover, Germany, D-30625
Sponsors and Collaborators
Hannover Medical School
Investigators
Study Chair: Mathias Freund, MD Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000078432, GER-ALL-REZ-02/92, EU-93001
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00002532     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Dexamethasone
Anti-Inflammatory Agents
Methylprednisolone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Methotrexate
Etoposide
Methylprednisolone Hemisuccinate
Asparaginase
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Glucocorticoids
Folic Acid
Idarubicin
Antimetabolites
Daunorubicin
Leukemia, Lymphoid
Immunologic Factors
Vindesine
Folate
Leucovorin
Prednisolone acetate
Etoposide phosphate
Vitamin B9
Leukemia
Anti-Bacterial Agents
Vitamins

Additional relevant MeSH terms:
Dexamethasone
Anti-Inflammatory Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Asparaginase
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Hormonal
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Idarubicin
Neoplasms
Antimetabolites
Daunorubicin
Leukemia, Lymphoid
Immunologic Factors
Antineoplastic Agents
Leucovorin
Reproductive Control Agents

ClinicalTrials.gov processed this record on July 02, 2009