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Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) (IND 104224)

This study has been terminated.
(Study was terminated due to lack of accrual.)
Sponsor:
Information provided by:
Therapeutic Advances in Childhood Leukemia Consortium
ClinicalTrials.gov Identifier:
NCT00928200
First received: June 24, 2009
Last updated: August 18, 2010
Last verified: August 2010
  Purpose

This is a phase I study using the Erwinia form of asparaginase in place of the E. coli form using a standard re-induction regimen (Vincristine, Dexamethasone, Doxorubicin) for patients with relapsed ALL who have developed an allergy to the E. coli formulation. This study will administer the drug intravenously instead of the usual intramuscular route. The dose of Erwinia will be escalated in the absence of dose limiting toxicity. Patients must have first or second relapse ALL with a history of prior systemic reaction to E. coli asparaginase.


Condition Intervention Phase
Relapsed Acute Lymphoblastic Leukemia
Allergy to PEG e.Coli Asparaginase
Allergy to Native e.Coli Asparaginase
Drug: Erwinase
Drug: Vincristine
Drug: Dexamethasone
Drug: Doxorubicin
Drug: Cytarabine
Drug: Methotrexate
Drug: Triple Intrathecal Therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravenous Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia and Allergy to E. Coli Asparaginase (IND 104224)

Resource links provided by NLM:


Further study details as provided by Therapeutic Advances in Childhood Leukemia Consortium:

Primary Outcome Measures:
  • Maximum Tolerated Dose [ Time Frame: Each dose level is evaluated ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: May 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Erwinase
    The dose of Erwinase will be assigned at study entry. Erwinase will be administered as a 2-hour intravenous infusion. A total of 10 doses will be given on a Monday-Wednesday-Friday schedule.
    Drug: Vincristine
    1.5 mg/m2/dose IV push on days 1, 8, 15 and 22
    Drug: Dexamethasone
    10 mg/m2/day divided BID. Give by mouth days 1-14
    Drug: Doxorubicin
    60 mg/m2/day IV over 15 minutes on day 1
    Drug: Cytarabine
    Given Intrathecally at the dose defined by age on day 1. 30 mg for age 1-1.99 50 mg for age 2-2.99 70 mg for age 3 and older
    Drug: Methotrexate
    Given Intrathecally to all patients with CNS negative disease at study entry. Dose defined by age. Given on day 15 8mg for age 1-1.99 10 mg for age 2-2.99 12 mg for age 3-8.99 15 mg for age 9 and older
    Drug: Triple Intrathecal Therapy
    Methotrexate, Cytarabine and Hydrocortisone given Intrathecally on day 8, 15 and 22 for patients who are CNS positive at study entry. Doses determined by age.
  Eligibility

Ages Eligible for Study:   1 Year to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Abbreviated List of Eligibility Criteria

Inclusion Criteria:

  • Patients must have relapsed or refractory acute lymphoblastic leukemia with a M3 marrow (marrow blasts >25%) who have had no more than two prior therapeutic attempts.
  • Patients must have a history of prior systemic allergic reaction to E. coli asparaginase (native or pegylated), such as urticaria, wheezing, or anaphylaxis.
  • Patients may be in first or second relapse and should not have received more than 2 induction attempts.
  • Patients must have less than 350mg/m2 lifetime exposure of anthracycline chemotherapy.
  • Patients should not have received previous therapy using Erwinase.

Exclusion Criteria:

  • Patients with prior history of Grade 2 or greater asparaginase-induced symptomatic pancreatitis will be excluded.
  • Patients with a prior history of asparaginase associated stroke are excluded.
  • Patients will be excluded if their shortening fraction by echocardiogram is less than 30%.
  • Patients who are pregnant or nursing an infant.

LABS

  • Direct bilirubin > 1.5x the institutional upper limit of normal for age. A total bilirubin result that is less than 1.5 times the institutional upper limit of normal for age may be used for eligibility if a direct bilirubin result is not available.
  • SGPT (ALT) > 4 x institutional upper limit of normal
  • Amylase or Lipase > 2 x institutional upper limit of normal
  • Serum creatinine is > the upper limit of normal for age at the institution's laboratory.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928200

Locations
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States
United States, California
City of Hope
Duarte, California, United States, 91010
Miller Children's Hospital
Long Beach, California, United States
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
Oakland Children's Hospital
Oakland, California, United States
Stanford University Medical Center
Palo Alto, California, United States, 94304-1812
UCSF School of Medicine
San Francisco, California, United States, 94143-0106
United States, Florida
University of Miami Cancer Center
Miami, Florida, United States, 33136
United States, Illinois
Children's Memorial
Chicago, Illinois, United States
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States
United States, Michigan
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109-0914
United States, Minnesota
Childrens Hospital & Clinics of Minnesota
Minneapolis, Minnesota, United States, 55404-4597
University of Minnesota Children's Hospital
Minneapolis, Minnesota, United States
United States, New York
Children's Hospital New York-Presbyterian
New York, New York, United States, 10032
New York University Medical Center
New York, New York, United States, 10016
United States, Ohio
Nationwide Childrens Hospital
Columbus, Ohio, United States
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States
United States, Tennessee
Vanderbilt Children's Hospital
Nashville, Tennessee, United States
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Canada, Ontario
Hospital for Sick Kids
Toronto, Ontario, Canada
Sponsors and Collaborators
Therapeutic Advances in Childhood Leukemia Consortium
Investigators
Study Chair: Heather Grossman, MD Children's Hopital New York
Principal Investigator: Paul Gaynon, md Therapeutic Advances in Childhood Leukemia
  More Information

Additional Information:
No publications provided

Responsible Party: Heather Grossman, Therapeutic Advances in Childhood Leukemia Consortium
ClinicalTrials.gov Identifier: NCT00928200     History of Changes
Other Study ID Numbers: T2006-002
Study First Received: June 24, 2009
Last Updated: August 18, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Brazil: National Committee of Ethics in Research
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Therapeutic Advances in Childhood Leukemia Consortium:
Relapsed
Allergy
Erwinia
Acute
Lymphoblastic
Leukemia

Additional relevant MeSH terms:
Hypersensitivity
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Asparaginase
Cytarabine
Dexamethasone
Methotrexate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Antiviral Agents
Autonomic Agents
Central Nervous System Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on November 20, 2014