Erwinia Asparaginase After Allergy to PEG-Asparaginase in Treating Young Patients With Acute Lymphoblastic Leukemia - NCT00537030-76104 (Clinical Trial 186396)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy186396.aspx
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| City: |
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Fort Worth |
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State:
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TX |
| Zip Code: |
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76104 |
| Conditions: |
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Leukemia |
| Purpose: |
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RATIONALE: Drugs used in chemotherapy, such as Erwinia asparaginase, work in different ways
to stop the growth of cancer cells, either by killing the cells or by stopping them from
dividing.
PURPOSE: This clinical trial is studying the side effects of Erwinia asparaginase and what
happens to the drug in the body in treating young patients with acute lymphoblastic leukemia
who are allergic to PEG-asparaginase.
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| Study summary: |
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OBJECTIVES:
Primary
- To determine if the 48-hour trough serum asparaginase activity is ≥ 0.1 IU/mL in young
patients with acute lymphoblastic leukemia treated with Erwinia asparaginase after
allergy to PEG-asparaginase.
- To determine the frequency of asparaginase-related toxicity in these patients.
- To characterize the pharmacokinetics of Erwinia asparaginase in these patients.
Secondary
- To compare serum asparaginase activity and serum asparagine concentration between
patients treated with Erwinia asparaginase on this trial and historical controls
treated with PEG-asparaginase on CCG-1961 and CCG-1962.
- To determine the 72-hour serum asparaginase activity on days 8 or 11 or 13 based on the
starting date of Erwinia asparaginase therapy.
- To determine the presence of anti-Erwinia asparaginase antibodies in patients treated
with a course(s) of Erwinia asparaginase following clinical allergy to PEG-asparaginase
(PEG, pegaspargase).
- To determine if serum asparagine is adequately depleted on days 12 or 13 in a subset of
these patients.
OUTLINE: This is a multicenter study.
Patients receive 6 doses of Erwinia asparaginase intramuscularly on a
Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of
PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy
continues according to the original treatment protocol.
Blood samples are collected periodically for pharmacokinetic, pharmacodynamic, and antibody
studies.
After completion of study treatment, patients are followed periodically. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- Diagnosis of acute lymphoblastic leukemia
- Concurrently enrolled on a frontline Children's Oncology Group treatment trial (i.e.,
COG-AALL0232 or COG-AALL0531, COG-AALL0331, or COG-AALL0434) at a participating
institution
- Must have 1 or more courses of asparaginase remaining to be administered on the
treatment protocol
- Must have had a grade ≥ 2 hypersensitivity reaction to PEG-asparaginase
PATIENT CHARACTERISTICS:
- No history of pancreatitis ≥ grade 2
PRIOR CONCURRENT THERAPY:
- No prior Erwinia asparaginase |
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| Study is available at: |
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Cook Children's Medical Center - Fort Worth
Fort Worth, TX 76104
United States
Primary Contact:
Clinical Trials Office - Cook's Children's Medical Center
Phone: 682-885-2103 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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