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Study Summary
No. COG ACNS0121:.......Other Studies......Joann L. Ater......Pediatrics
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Study Summary Title
Study Summary
Number:
COG ACNS0121
Study Title:A Phase II Trial of Conformal Radiation Therapy for Pediatric Patients W/ Localized Ependymoma, Chemotherapy Prior to Second Surgery For Incompletely Resected Ependymoma & Observation For Completely Resected, Differentiated, Supratentorial Ependymoma
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Physician New Patient Referral
Name:Joann L. AterPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:PediatricsReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-6665
Contact us about clinical trials
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General Information
Disease Group:Other StudiesSupported By:NCI/COG
Phase of Study:Phase IIReturn
Visit:
Following protocol therapy, all patients will return for follow-up visits and/or evaluations every 4 months for the first 3 years. Then every 6 months for years 4-5. Annually thereafter. Refer to protocol for specific details of visits.
Treatment
Agents:
Treatment information not availableHome Care:Etoposide 50mg pink capsules may be administered orally at home, according to protocol guidelines. Granulocyte colony-stimulating factor may be administered subcutaneously at home, according to protocol guidelines.
Treatment Loc:both inpatient and outpatient
Estimated
Length of Stay
in Houston:
Str patients may be hospitalized for chemotherapy (2-3 days) or a 2nd surgery; duration will be determined by the physician. NTR/GTR2 & GTR1 patients may be hospitalized for radiation treatment; duration will be determined by the physician.
Description/
Intervention:
Unavailable
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Study Objectives / Outcomes
Unavailable
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Study Status Information
Study Activation / Registration Date:08/17/2004
IRB Review and Approval Date:01/07/2004
Study Type:Therapeutic
Recruitment Status:Open
Projected Accrual:25
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:Patients must be enrolled on study within 56 days of initial surgical resection. Enrollment longer than 56 days after initial surgery will require written consent by the study chair

Patients receiving chmotherapy or radiation therapy must be enrolled prior to start of these therapies. The start of treatment must be planned to begin within 14 days of study enrollment

Patients must be greater than 12 months and less than 21 years at the time of enrollment

Histologically confirmed intracranial ependymoma. Patients with differentiated ependymoma or anaplastic ependymoma are eligible. Patients with primary spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed gliomas are not eligible

No evidence of non-contiguous spread beyond the primary site as determined by post-operative MR imaging of brain and pre or post-operative MR of the spine and CSF cytology obtained from the lumbar CSF space (the requirement for lumbar CSF examination may be waived if deemed to be medically contraindicated)

There is no minimum performance level. Children with ependymoma may suffer neurologic sequelae as a result of their tumor or surgical measures taken to establish a diagnosis and resect the tumor. In the majority of cases there is neurologic recovery. Neurologic recovery is not likely to be impeded by protocol therapy

No prior treatment other than surgical intervention and corticosteroids. Patients who have had more than one surgery will be eligible. Corticosteroid therapy is permissible

Appropriate antibiotics, blood products, antiemetics, fluids, electrolytes and general supportive care are to be used as necessary. There is no minimum hemoglobin level during radiation therapy

All patients and/or their parents or legal guardians must sign a written informed consent prior to study enrollment

All institutional, FDA, and NCI requirements for human studies must be met

Exclusion Criteria:Patients who are unable to undergo MR imaging (ie MR incompatible vascular clips)

Patients who are pregnant or breast feeding will not be eligible. Patients of childbearing potential must practice an effective method of birth control while participating on this study

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Links
Registration Number:

Other Links:
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Results


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