Erwinia Asparaginase After Allergy to PEG-Asparaginase in Treating Young Patients With Acute Lymphoblastic Leukemia
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Pharmacology and Toxicity of Erwinia Asparaginase (Erwinase®; Crisantaspase; IND 290) Following Allergy to PEG-Asparaginase in Treatment of Children With Acute Lymphoblastic Leukemia (ALL)|
- Trough serum asparaginase activity as assessed at 48 hours [ Designated as safety issue: No ]
- Frequency of asparaginase-related toxicities as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
- Serum asparagine depletion (assessed at participating phase I institutions only) [ Designated as safety issue: No ]
- Presence of specific anti-Erwinia and anti-PEG-asparaginase antibodies at baseline, and of specific anti-Erwinia antibodies after first and subsequent exposures to Erwinia asparaginase as assessed by ELISA [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
- 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.
- 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.