Overview

This trial is active, not recruiting.

Conditions adult acute lymphoblastic leukemia, childhood acute lymphoblastic leukemia
Treatments laboratory biomarker analysis, pharmacological study, asparaginase
Sponsor Children's Oncology Group
Collaborator National Cancer Institute (NCI)
Start date February 2008
End date February 2011
Trial size 59 participants
Trial identifier NCT00537030, AALL07P2, CDR0000566349, COG-AALL07P2, NCI-2009-00316, U10CA098543

Summary

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. 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients receive 6 doses of Erwinia asparaginase (dosage 25,000 IU/m2 intramuscularly (IM) 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.
laboratory biomarker analysis
Correlative studies
pharmacological study pharmacological studies
Correlative studies
asparaginase ASNase
Given IM

Primary Outcomes

Measure
Trough Serum Asparaginase Activity
time frame: Measured in blood at 48 hours post administration of Erwinia asparaginase

Secondary Outcomes

Measure
Determine if Plasma Asparagine is Adequately Depleted
time frame: On days 12 or 13
Presence of Anti-Erwinia Asparaginase Antibodies in Children Treated With a Course(s) of Erwinase® Following Clinical Allergy to PEG-asparaginase
time frame: At baseline, prior to doses 4, 5, and 6 and on days 15 and 22
Frequency of Asparaginase-related Toxicities Following Erwinase® Treatment.
time frame: At each course of Erwinase® treatment

Eligibility Criteria

Male or female participants from 1 year up to 30 years old.

Inclusion Criteria: - 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 - No history of pancreatitis ≥ grade 2 - No prior Erwinia asparaginase

Additional Information

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)
Principal investigator Wanda Salzer, MD
Description Primary Aims 1. To determine if the 48 hour trough serum asparaginase activity is ≥0.1 IU/mL. 2. To determine the frequency of asparaginase-related toxicity following Erwinase® treatment. 3. To characterize the pharmacokinetics of Erwinase in children with leukemia and allergy to PEG-asparaginase. Secondary 1. To informally compare serum asparaginase activity and plasma asparagine concentration between patients treated with Erwinase® on this trial and historical controls treated with PEG-asparaginase on CCG-1962 and 1961. 2. To determine the 72 hour serum asparaginase activity (Day 8 (pre-dose 4) if the course of Erwinase® is started on Monday; Day 13 (pre-dose 6) if the course of Erwinase® is started on Wednesday; and Day 11 (pre-dose 5) if the course of Erwinase® is started on Friday). 3. To determine the presence of anti-Erwinia asparaginase antibodies in children treated with a course(s) of Erwinase® following clinical allergy to PEG -asparaginase (PEG, pegaspargase). 4. To determine if plasma asparagine is adequately depleted (Day 12 (pre-dose 6) if the course of Erwinase® is started on Monday; Day 13 (pre-dose 6) if the course of Erwinase® is started on Wednesday or Friday) in a subset of patients. Patients receive 6 doses of Erwinia asparaginase intramuscularly (IM) 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Children's Oncology Group.