Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) (IND 104224)
Overview[ - collapse ][ - ]
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. |
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Condition | Relapsed Acute Lymphoblastic Leukemia Allergy to PEG e.Coli Asparaginase Allergy to Native e.Coli Asparaginase |
Intervention | Drug: Erwinase Drug: Vincristine Drug: Dexamethasone Drug: Doxorubicin Drug: Cytarabine Drug: Methotrexate Drug: Triple Intrathecal Therapy |
Phase | Phase 1 |
Sponsor | Therapeutic Advances in Childhood Leukemia Consortium |
Responsible Party | Therapeutic Advances in Childhood Leukemia Consortium |
ClinicalTrials.gov Identifier | NCT00928200 |
First Received | June 24, 2009 |
Last Updated | August 18, 2010 |
Last verified | August 2010 |
Tracking Information[ + expand ][ + ]
First Received Date | June 24, 2009 |
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Last Updated Date | August 18, 2010 |
Start Date | May 2009 |
Estimated Primary Completion Date | June 2010 |
Current Primary Outcome Measures | Maximum Tolerated Dose [Time Frame: Each dose level is evaluated] [Designated as safety issue: Yes] |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) (IND 104224) |
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Official Title | Intravenous Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia and Allergy to E. Coli Asparaginase (IND 104224) |
Brief Summary | 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. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition |
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Intervention | 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. |
Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Terminated |
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Estimated Enrollment | 30 |
Estimated Completion Date | June 2010 |
Estimated Primary Completion Date | June 2010 |
Eligibility 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. |
Gender | Both |
Ages | 1 Year |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, Canada |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00928200 |
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Other Study ID Numbers | T2006-002 |
Has Data Monitoring Committee | Yes |
Information Provided By | Therapeutic Advances in Childhood Leukemia Consortium |
Study Sponsor | Therapeutic Advances in Childhood Leukemia Consortium |
Collaborators | Not Provided |
Investigators | Study Chair: Heather Grossman, MD Children's Hopital New YorkPrincipal Investigator: Paul Gaynon, md Therapeutic Advances in Childhood Leukemia |
Verification Date | August 2010 |
Locations[ + expand ][ + ]
Phoenix Children's Hospital | Phoenix, Arizona, United States |
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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 |
University of Miami Cancer Center | Miami, Florida, United States, 33136 |
Children's Memorial | Chicago, Illinois, United States |
Johns Hopkins University | Baltimore, Maryland, United States |
C.S. Mott Children's Hospital | Ann Arbor, Michigan, United States, 48109-0914 |
Childrens Hospital & Clinics of Minnesota | Minneapolis, Minnesota, United States, 55404-4597 |
University of Minnesota Children's Hospital | Minneapolis, Minnesota, United States |
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 |
Nationwide Childrens Hospital | Columbus, Ohio, United States |
Oregon Health and Science University | Portland, Oregon, United States |
Vanderbilt Children's Hospital | Nashville, Tennessee, United States |
Seattle Children's Hospital | Seattle, Washington, United States, 98105 |
Hospital for Sick Kids | Toronto, Ontario, Canada |