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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00316 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 07-162 | |||
| COG-AALL07P2 | |||
| CDR0000566349 | |||
| AALL07P2 | Other Identifier | Childrens Oncology Group | |
| AALL07P2 | Other Identifier | CTEP | |
| U10CA098543 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
PRIMARY OBJECTIVES:
I. 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.
II. To determine the frequency of asparaginase-related toxicity in these patients.
III. To characterize the pharmacokinetics of Erwinia asparaginase in these patients.
SECONDARY OBJECTIVES:
I. 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.
II. To determine the 72-hour serum asparaginase activity on days 8 or 11 or 13 based on the starting date of Erwinia asparaginase therapy.
III. 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).
IV. 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 (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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (chemotherapy) | Experimental | Patients receive 6 doses of Erwinia asparaginase 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asparaginase | Drug | Given IM |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Trough Serum Asparaginase Activity ≥ 0.1 IU/mL | Percentage of participants who had trough serum asparaginase activity ≥ 0.1 IU/mL in the blood 48 hours post administration of Erwinia asparaginase | 48 hours post administration of Erwinia asparaginase |
| Measure | Description | Time Frame |
|---|---|---|
| Determine if Plasma Asparagine is Adequately Depleted | Plasma asparagine depletion will be determined in a subset of 20 patients limited to participating Phase I Institutions. | 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 |
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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 had a grade ? 2 hypersensitivity reaction to PEG-asparaginase
No history of pancreatitis ? grade 2
No prior Erwinia asparaginase
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| Name | Affiliation | Role |
|---|---|---|
| Wanda Salzer | Children's Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | 35233 | United States | ||
| Phoenix Childrens Hospital |
Confirmation of the patient ineligibility was not confirmed by the COG study team until the patient received their first dose of Erwinia. Patient was removed from the COG frontline study (AALL08P1) prior to enrollment of this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Erwinia Asparaginase | 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. pharmacological study : Correlative studies laboratory biomarker analysis : Correlative studies asparaginase : Given IM |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Pharmacological Study | Other | Correlative studies |
|
An ELISA (enzyme-linked immunosorbent assay) method will be used to determine the presence of specific anti-Erwinia and anti-PEG-asparaginase antibodies at baseline, and of specific anti-Erwinia asparaginase antibodies after first and subsequent exposures to Erwinase®. The rate of antibody formation will be described and compared informally to experience in CCG-1962 and 1961. Serum asparaginase activity will be compared during Erwinase® courses as an indication of the neutralizing effect of antibodies on the enzyme effect. |
| At baseline, prior to doses 4, 5, and 6 and on days 15 and 22 |
| Percentage of Participants Who Experienced Toxicities | The percentage of participants who experienced toxicities: Allergy rate, Hyperglycemia Rate, Pancreatitis Rate, Hemorrhage/Thrombosis Rate | up to 1 year |
| Phoenix |
| Arizona |
| 85016 |
| United States |
| Kaiser Permanente Downey Medical Center | Downey | California | 90242 | United States |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| Children's Hospital Central California | Madera | California | 93636-8762 | United States |
| Children's Hospital of Orange County | Orange | California | 92868 | United States |
| Rady Children's Hospital - San Diego | San Diego | California | 92123 | United States |
| UCSF Medical Center-Mount Zion | San Francisco | California | 94115 | United States |
| UCSF Medical Center-Parnassus | San Francisco | California | 94143 | United States |
| Harbor-University of California at Los Angeles Medical Center | Torrance | California | 90502 | United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Nemours Children's Clinic-Jacksonville | Jacksonville | Florida | 32207 | United States |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| Lurie Children's Hospital-Chicago | Chicago | Illinois | 60611 | United States |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453-2699 | United States |
| Advocate Children's Hospital-Oak Lawn | Oak Lawn | Illinois | 60453 | United States |
| Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Norton Children's Hospital | Louisville | Kentucky | 40202 | United States |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | United States |
| Spectrum Health at Butterworth Campus | Grand Rapids | Michigan | 49503 | United States |
| Kalamazoo Center for Medical Studies | Kalamazoo | Michigan | 49008 | United States |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | 55404 | United States |
| University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| The Childrens Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park | New York | 11040 | United States |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | United States |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Rainbow Babies and Childrens Hospital | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Saint Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134 | United States |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | United States |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | United States |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Erwinia Asparaginase | 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. pharmacological study : Correlative studies laboratory biomarker analysis : Correlative studies asparaginase : Given IM |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Trough Serum Asparaginase Activity ≥ 0.1 IU/mL | Percentage of participants who had trough serum asparaginase activity ≥ 0.1 IU/mL in the blood 48 hours post administration of Erwinia asparaginase | Of the 59 enrolled participants, there were 2 ineligible and 2 in-evaluable participants. From the remaining 55 participants, 52 participants had an acceptable sample that could be reported on. | Posted | Number | Percent of participants | 48 hours post administration of Erwinia asparaginase |
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| Secondary | Determine if Plasma Asparagine is Adequately Depleted | Plasma asparagine depletion will be determined in a subset of 20 patients limited to participating Phase I Institutions. | No data available for this analysis. | Posted | On days 12 or 13 |
|
| |||||||||||||||||||||||||||||
| Secondary | Presence of Anti-Erwinia Asparaginase Antibodies in Children Treated With a Course(s) of Erwinase® Following Clinical Allergy to PEG-asparaginase | An ELISA (enzyme-linked immunosorbent assay) method will be used to determine the presence of specific anti-Erwinia and anti-PEG-asparaginase antibodies at baseline, and of specific anti-Erwinia asparaginase antibodies after first and subsequent exposures to Erwinase®. The rate of antibody formation will be described and compared informally to experience in CCG-1962 and 1961. Serum asparaginase activity will be compared during Erwinase® courses as an indication of the neutralizing effect of antibodies on the enzyme effect. | no data available for this analysis. | Posted | At baseline, prior to doses 4, 5, and 6 and on days 15 and 22 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experienced Toxicities | The percentage of participants who experienced toxicities: Allergy rate, Hyperglycemia Rate, Pancreatitis Rate, Hemorrhage/Thrombosis Rate | Patients who had toxicity data collected. | Posted | Number | percentage of participants | up to 1 year |
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Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. There were 2 ineligible and 2 in-evaluable patients excluded from reporting of adverse events, leaving a total of 55 participants included in the AE
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erwinia Asparaginase | 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. pharmacological study : Correlative studies laboratory biomarker analysis : Correlative studies asparaginase : Given IM | 9 | 55 | 15 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | CTC version 4 | Systematic Assessment |
| |
| Fever | General disorders | CTC version 4 | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTC version 4 | Systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | CTC version 4 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTC version 4 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTC version 4 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTC version 4 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTC version 4 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTC version 4 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTC version 4 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTC version 4 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | CTC version 4 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTC version 4 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | CTC version 4 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTC version 4 | Systematic Assessment |
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| Fatigue | General disorders | CTC version 4 | Systematic Assessment |
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| Allergic reaction | Immune system disorders | CTC version 4 | Systematic Assessment |
| |
| Radiation recall reaction (dermatologic) | Injury, poisoning and procedural complications | CTC version 4 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | CTC version 4 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | CTC version 4 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | CTC version 4 | Systematic Assessment |
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| Lipase increased | Investigations | CTC version 4 | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTC version 4 | Systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | CTC version 4 | Systematic Assessment |
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| Headache | Nervous system disorders | CTC version 4 | Systematic Assessment |
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| Agitation | Psychiatric disorders | CTC version 4 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | CTC version 4 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Results Reporting Coordinator | Children's Oncology Group | 626-447-0064 | resultsreportingcoordinator@childrensoncologygroup.org |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D001215 | Asparaginase |
| C001176 | Leyk |
| ID | Term |
|---|---|
| D000581 | Amidohydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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