Long-term Effects Secondary to Cancer Therapy in ChildrenNCT00028509
Brain Function in Children Previously Treated on Clinical Trials POG-9605 and POG-9201
An observational study of Long-term Effects Secondary to Cancer Therapy in Children and Neurotoxicity, run by Children's Oncology Group at 26 sites in 2 countries.
Trial summary
RATIONALE: Assessing the effects of methotrexate on brain function in children may improve the ability to plan treatment and decrease side effects. PURPOSE: Clinical trial to compare brain function of children who have been previously treated with methotrexate. Read more about this study
- Who is it for?
- Ages 1 year to 9 years
- Conditions the study is for
- Long-term Effects Secondary to Cancer Therapy in Children, Neurotoxicity
- What is being tested?
- management of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- 66 participants
- Where
- 26 sitesin 2 countries
- Study dates
- Jul 2002to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 9 years
- All sexes
- No healthy volunteers
- Child
Study population: Previously enrolled on POG-9201 or POG-9605
DISEASE CHARACTERISTICS:
- Previously enrolled on POG-9201 or POG-9605
- Good prognosis by NCI risk (9201 and 9605 stratum 1)
- Eligible for the therapeutic study
- Completed therapy by 12/31/2000
- No CNS3 at diagnosis
- No relapsed disease
PATIENT CHARACTERISTICS:
Age:
- 1 to 9 at diagnosis
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No Down syndrome
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- See Disease Characteristics
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
United States25 sites
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, 87131-5636
CancerCare of Maine at Eastern Maine Medial Center
Bangor, Maine, 04401
Floating Hospital for Children at Tufts - New England Medical Center
Boston, Massachusetts, 02111
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, 28232-2861
Rush University Medical Center
Chicago, Illinois, 60612
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
Hurley Medical Center
Flint, Michigan, 48503
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, 48236
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, 07601
Cancer Research Center of Hawaii
Honolulu, Hawaii, 95813
Baylor University Medical Center - Houston
Houston, Texas, 77030-2399
University of Mississippi Cancer Clinic
Jackson, Mississippi, 39216-4505
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, 33136
Miami Children's Hospital
Miami, Florida, 33155
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, 73104
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78207
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, 63110
Stanford Comprehensive Cancer Center - Stanford
Stanford, California, 94305
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa, Florida, 33607
Kaplan Cancer Center at St. Mary's Medical Center
West Palm Beach, Florida, 33407
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
Canada1 site
Montreal Children's Hospital at McGill University Health Center
Montreal, Quebec, H3H 1P3
About this study
Official title: Assessment of Clinical and Neuroradiologic Evidence of Methotrexate Leukoencephalopathy in Children Treated on POG 9605 and 9201
RATIONALE: Assessing the effects of methotrexate on brain function in children may improve the ability to plan treatment and decrease side effects.
PURPOSE: Clinical trial to compare brain function of children who have been previously treated with methotrexate.
Read the detailed description
OBJECTIVES:
- Compare the incidence of neuropsychological abnormalities and leukoencephalopathy in children previously treated with methotrexate on protocols POG-9605 versus POG-9201.
OUTLINE: This is a multicenter study.
More than 3 years after completion of therapy, patients undergo 9 different tests to assess intelligence, memory, learning, attention, concentration, processing of information, functioning, and visual-motor integration. Patients also undergo MRI of the head.
PROJECTED ACCRUAL: A total of 30-54 patients previously treated on protocol POG-9201 will be accrued for this study. A total of 60-108 patients previously treated on protocol POG-9605 will be accrued for this study.
- Being tested
- management of therapy complications
- Keywords
- neurotoxicity, long-term effects secondary to cancer therapy in children
- Medical subject headings
- Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
management of therapy complicationsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with severe intelligence deficit as evidenced by either a verbal or performance IQ below 85
Measured: Length of study
Secondary outcomes (1)
Compare the groups for descriptive purposes
Quantitative scales: IQ (WISC III or WPPSI-R, depending on the age of the child), Wide Range Assessment of Memory and Learning (4 subscales), Conner's Continuous Performance Test (Attention/Concentration), Woodcock Johnson Revised Processing Speed Cluster, NEPSP Tower Tests (Executive Functioning), and VSI (Visual-Motor Integration).
Measured: Length of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJul 2002
- Primary completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long-term Effects Secondary to Cancer Therapy in ChildrenStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Patricia K. Duffner, MD, Study chair, Women & Children's Hospital of Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00028509
- Sponsor's protocol ID
- ACCL0131
- Other IDs
- COG-ACCL0131, NCI-P01-0198, CDR0000069100
- Status last verified
- Feb 2014
- First submitted
- 4 Jan 2002
- Last updated
- 13 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Clinical and Neuroradiologic Evidence of Methotrexate Leukoencephalopathy in Children Treated on POG 9605 and 9201
- ClinicalTrials.gov ID
- NCT00028509
- Acronym / sponsor ID
- ACCL0131
- Keywords
- neurotoxicity, long-term effects secondary to cancer therapy in children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2002
- Primary completion
- Jul 2011 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Assessing the effects of methotrexate on brain function in children may improve the ability to plan treatment and decrease side effects.
PURPOSE: Clinical trial to compare brain function of children who have been previously treated with methotrexate.
Detailed description
OBJECTIVES:
- Compare the incidence of neuropsychological abnormalities and leukoencephalopathy in children previously treated with methotrexate on protocols POG-9605 versus POG-9201.
OUTLINE: This is a multicenter study.
More than 3 years after completion of therapy, patients undergo 9 different tests to assess intelligence, memory, learning, attention, concentration, processing of information, functioning, and visual-motor integration. Patients also undergo MRI of the head.
PROJECTED ACCRUAL: A total of 30-54 patients previously treated on protocol POG-9201 will be accrued for this study. A total of 60-108 patients previously treated on protocol POG-9605 will be accrued for this study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Previously enrolled on POG-9201 or POG-9605
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| management of therapy complications | Procedure or surgery | – |
Primary outcome
Percentage of patients with severe intelligence deficit as evidenced by either a verbal or performance IQ below 85
Time frame: Length of study
1 secondary outcome
Compare the groups for descriptive purposes
Time frame: Length of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia K. Duffner, MD study chair
Women & Children's Hospital of Buffalo
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long-term Effects Secondary to Cancer Therapy in Children and Neurotoxicity, run by Children's Oncology Group at 26 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with severe intelligence deficit as evidenced by either a verbal or performance IQ below 85 (time frame: Length of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2014; AzTrials last refreshed its copy on 31 Oct 2026.