Erwinia Asparaginase After Allergy to PEG-Asparaginase in Treating Young Patients With Acute Lymphoblastic Leukemia - Full Text View

Sponsor:	Children's Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00537030

Purpose

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.

Condition	Intervention
Leukemia	Drug: asparaginase Erwinia chrysanthemi

Study Type:	Interventional
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)

Resource links provided by NLM:

MedlinePlus related topics: Acute Lymphocytic Leukemia Allergy Cancer Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: Pegaspargase L-Asparaginase

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	55
Study Start Date:	February 2008
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	1 Year to 30 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537030

Show 45 Study Locations

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Wanda L. Salzer, MD

NCI - Pediatric Oncology Branch

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00537030 History of Changes
Other Study ID Numbers:	CDR0000566349, COG-AALL07P2
Study First Received:	September 27, 2007
Last Updated:	November 19, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult acute lymphoblastic leukemia
childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases

Immunoproliferative Disorders
Immune System Diseases
Pegaspargase
Asparaginase
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012