A Trial of Surgery and Fractionated Re-Irradiation for Recurrent Ependymoma
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 1 - 21 |
| Updated: | 10/24/2018 |
| Start Date: | May 7, 2014 |
| End Date: | September 2025 |
| Contact: | Thomas E. Merchant, DO, PhD |
| Email: | referralinfo@stjude.org |
| Phone: | 866-278-5833 |
A Phase II Trial of Surgery and Fractionated Re-Irradiation for Recurrent Ependymoma
The primary purpose of this study is to investigate whether surgery and re-irradiation will
help treat ependymoma that has come back after initial treatment. The combined doses of the
first and second courses of radiation are higher than what is usual standard of care. The
investigators will study the effects and side effects of surgery and re-irradiation. They
will also evaluate and study tumor tissue and blood to learn more about the tumor and how it
does or does not respond to treatments and will use magnetic resonance imaging (MRI) and
positron emission tomography (PET) scans to see if they can predict tumor response and tumor
recurrence.
Participants will be followed for up to 5 years following enrollment. Evaluations during
radiation therapy will be done weekly while receiving therapy for up to 7 weeks. Other
evaluations will be done at enrollment, every 4 months from enrollment through 3 years, and
every 6 months during the 4th and 5th year.
help treat ependymoma that has come back after initial treatment. The combined doses of the
first and second courses of radiation are higher than what is usual standard of care. The
investigators will study the effects and side effects of surgery and re-irradiation. They
will also evaluate and study tumor tissue and blood to learn more about the tumor and how it
does or does not respond to treatments and will use magnetic resonance imaging (MRI) and
positron emission tomography (PET) scans to see if they can predict tumor response and tumor
recurrence.
Participants will be followed for up to 5 years following enrollment. Evaluations during
radiation therapy will be done weekly while receiving therapy for up to 7 weeks. Other
evaluations will be done at enrollment, every 4 months from enrollment through 3 years, and
every 6 months during the 4th and 5th year.
Stratification for treatment will be determined when radiation therapy planning is initiated.
Patients will be stratified for outcome according to diagnosis and prior therapy.
- Stratum 1 (initial pattern of failure is local); disease confined to primary site; age
>12 months at time of enrollment to < 21 years. Treatment: focal irradiation.
- Stratum 2 (initial pattern of failure is metastatic); neuraxis metastatic disease
without equivocal evidence of local failure; age > 36 months at time of enrollment to <
21 years. Treatment: craniospinal irradiation.
- Stratum 3 (Initial pattern of failure is both local and metastatic): neuraxis metastatic
disease with unequivocal evidence of local failure; age > 36 months at time of
enrollment to < 21 years. Treatment: craniospinal irradiation.
- Stratum 4 (initial pattern of failure is local): disease confined to primary site, age
>36 months at time of enrollment to <21 years; tumor shows presence of 1g gain.
Treatment: craniospinal irradiation (optional).
PRIMARY OBJECTIVE:
- To prospectively estimate the progression-free and overall survival distributions for
children and young adults with recurrent ependymoma treated with a second course of
irradiation while monitoring for excessive central nervous system necrosis.
SECONDARY OBJECTIVES:
- To explore potential associations of clinical and treatment factors with the incidence
and severity of neurological, endocrine and cognitive deficits in children and young
adults with ependymoma treated with a second course of irradiation.
- Using specific measures of sleep quality, excessive daytime sleepiness, daytime
activity, fatigue, symptom distress, and quality of life, explore associations of sleep,
fatigue and quality of life with other measures of CNS effects, clinical and treatment
factors in children and young adults with ependymoma treated with a second course of
irradiation.
- To evaluate and explore differences in physical performance and movement in children and
young adults with ependymoma treated with a second course of irradiation.
- Estimate and compare the response of residual tumor and the incidence and severity of
structural, physiological, and vascular effects of normal brain in children and young
adults with ependymoma after treatment with a second course of irradiation using
specific methods of diffusion, contrast-enhancement, magnetization transfer, vascular
and functional neuroimaging, and explore the association between these and other
measures of CNS effects and clinical and treatment factors. Determine the time course of
gray matter and white matter tract injury and recovery post irradiation and the
association between imaging metrics derived from serial quantitative neural imaging and
radiation dosimetry as well as neuro-cognitive outcomes.
Other Pre-Specified (Exploratory) Objectives:
- Estimate the avidity of ependymoma to 18F-fluorodeoxyglucose (FDG) and 11C-methionine
positron emission tomography (IND # 104987) prior to radiation therapy and correlate
change in avidity 12, 24 and 36 months after a second course of irradiation with tumor
progression.
- Measure growth factor and cytokine responses in children and young adults with
ependymoma after treatment with a second course of irradiation, and explore associations
between these and other measures of CNS effects and clinical and treatment factors.
Descriptively compare findings for patients treated with an initial course of
irradiation.
- To conduct a variety of exploratory molecular analyses on tumor samples (and blood where
a germline control is required), including but not limited to broad (genome-wide /
array-based) or focused (gene-specific) analyses at the DNA, RNA, or protein level and
next generation (whole genome, exome, transcriptome) sequencing in an effort to improve
the investigators understanding of ependymoma biology, and to explore associations
between molecular findings and treatment response and various side effects including
vasculopathy, hearing loss, cognitive deficits, and growth hormone deficiency and other
measures as appropriate.
- To explore the association of chemotherapy given prior to re-irradiation with
progression-free survival and overall survival distributions
- To compare the progression-free and overall survival distributions for children (age >3
years) and young adults with recurrent ependymoma and 1g gain treated with a second
course of irradiation (focal or craniospinal) while monitoring for excessive central
nervous system necrosis.
Patients will be stratified for outcome according to diagnosis and prior therapy.
- Stratum 1 (initial pattern of failure is local); disease confined to primary site; age
>12 months at time of enrollment to < 21 years. Treatment: focal irradiation.
- Stratum 2 (initial pattern of failure is metastatic); neuraxis metastatic disease
without equivocal evidence of local failure; age > 36 months at time of enrollment to <
21 years. Treatment: craniospinal irradiation.
- Stratum 3 (Initial pattern of failure is both local and metastatic): neuraxis metastatic
disease with unequivocal evidence of local failure; age > 36 months at time of
enrollment to < 21 years. Treatment: craniospinal irradiation.
- Stratum 4 (initial pattern of failure is local): disease confined to primary site, age
>36 months at time of enrollment to <21 years; tumor shows presence of 1g gain.
Treatment: craniospinal irradiation (optional).
PRIMARY OBJECTIVE:
- To prospectively estimate the progression-free and overall survival distributions for
children and young adults with recurrent ependymoma treated with a second course of
irradiation while monitoring for excessive central nervous system necrosis.
SECONDARY OBJECTIVES:
- To explore potential associations of clinical and treatment factors with the incidence
and severity of neurological, endocrine and cognitive deficits in children and young
adults with ependymoma treated with a second course of irradiation.
- Using specific measures of sleep quality, excessive daytime sleepiness, daytime
activity, fatigue, symptom distress, and quality of life, explore associations of sleep,
fatigue and quality of life with other measures of CNS effects, clinical and treatment
factors in children and young adults with ependymoma treated with a second course of
irradiation.
- To evaluate and explore differences in physical performance and movement in children and
young adults with ependymoma treated with a second course of irradiation.
- Estimate and compare the response of residual tumor and the incidence and severity of
structural, physiological, and vascular effects of normal brain in children and young
adults with ependymoma after treatment with a second course of irradiation using
specific methods of diffusion, contrast-enhancement, magnetization transfer, vascular
and functional neuroimaging, and explore the association between these and other
measures of CNS effects and clinical and treatment factors. Determine the time course of
gray matter and white matter tract injury and recovery post irradiation and the
association between imaging metrics derived from serial quantitative neural imaging and
radiation dosimetry as well as neuro-cognitive outcomes.
Other Pre-Specified (Exploratory) Objectives:
- Estimate the avidity of ependymoma to 18F-fluorodeoxyglucose (FDG) and 11C-methionine
positron emission tomography (IND # 104987) prior to radiation therapy and correlate
change in avidity 12, 24 and 36 months after a second course of irradiation with tumor
progression.
- Measure growth factor and cytokine responses in children and young adults with
ependymoma after treatment with a second course of irradiation, and explore associations
between these and other measures of CNS effects and clinical and treatment factors.
Descriptively compare findings for patients treated with an initial course of
irradiation.
- To conduct a variety of exploratory molecular analyses on tumor samples (and blood where
a germline control is required), including but not limited to broad (genome-wide /
array-based) or focused (gene-specific) analyses at the DNA, RNA, or protein level and
next generation (whole genome, exome, transcriptome) sequencing in an effort to improve
the investigators understanding of ependymoma biology, and to explore associations
between molecular findings and treatment response and various side effects including
vasculopathy, hearing loss, cognitive deficits, and growth hormone deficiency and other
measures as appropriate.
- To explore the association of chemotherapy given prior to re-irradiation with
progression-free survival and overall survival distributions
- To compare the progression-free and overall survival distributions for children (age >3
years) and young adults with recurrent ependymoma and 1g gain treated with a second
course of irradiation (focal or craniospinal) while monitoring for excessive central
nervous system necrosis.
Inclusion Criteria:
- Progressive intracranial ependymoma after prior focal irradiation
- Patients aged 1-21 years at the time of enrollment
- Adequate performance status (ECOG < 3) and research participant does not require
mechanical ventilation
- Interval from start of initial radiation therapy to enrollment > 9 months
Exclusion Criteria:
- Prior craniospinal irradiation
- Pregnant women are excluded from enrollment on this study because radiation therapy is
an agent with the potential for teratogenic or abortifacient effects
- Any patient with both metastatic ependymoma and age < 3 years at the time of
enrollment
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Thomas E. Merchant, DO, PhD
Phone: 866-278-5833
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