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Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Ependymoma
Recruiting
I'm InterestedTrial ID: NCT01096368,7,26500
Purpose
The primary aim of this randomized phase III trial was to study whether the addition of
maintenance chemotherapy delivered after surgical resection and focal radiation would be
better than surgery and focal radiation alone. The trial also studied if patients who
received induction chemotherapy and then either achieved a complete response or went on to
have a complete resection would also benefit from maintenance chemotherapy. Children ages
1-21 years with newly diagnosed intracranial ependymoma were included. There were 2 arms that
were not randomized. One arm studied patients with Grade II tumors located in the
supratentorial compartment that were completely resected. One arm studied patients with
residual tumor and those patients all received maintenance chemotherapy after focal
radiation. Chemotherapy drugs, such as vincristine sulfate, carboplatin, cyclophosphamide,
etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by
killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving
more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy
uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a
high dose of radiation directly to the tumor may kill more tumor cells and cause less damage
to normal tissue. Giving chemotherapy in combination with radiation therapy may kill more
tumor cells and allow doctors to save the part of the body where the cancer started.
Official Title
Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients With Newly Diagnosed Ependymoma Ages 1 to 21 Years
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
- Patients must be newly diagnosed with histologically confirmed intracranial
ependymoma; patients with classic ependymoma (WHO II) or anaplastic ependymoma (WHO
III) are eligible, as are various subtypes described as clear cell, papillary,
cellular or a combination of the above
- 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
- REGULATORY: All patients and/or their parents or legal guardians must sign a written
informed consent
- REGULATORY: All institutional, Food and Drug Administration (FDA), and National Cancer
Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
- Patients with evidence of metastatic disease will be excluded; any evidence of
non-contiguous spread beyond the primary site as determined by pre or post-operative
magnetic resonance (MR) imaging of brain, pre or post-operative MR imaging of the
spine, and post-operative cerebrospinal fluid (CSF) cytology obtained from the lumbar
CSF space (the requirement for lumbar CSF examination may be waived if deemed to be
medically contraindicated); CSF cytology from a ventriculostomy or permanent
ventriculoperitoneal (VP) shunt that reveals the presence of tumor cells is indicative
of metastatic disease
- Patients with a diagnosis of spinal cord ependymoma, myxopapillary ependymoma,
subependymoma, ependymoblastoma, or mixed glioma are NOT eligible
- No prior treatment other than surgical intervention and corticosteroids; patients are
allowed to have had more than one attempt at resection prior to enrollment
- Pregnant female patients are not eligible for this study
- Post-menarchal females may not participate unless a pregnancy test with a negative
result has been obtained
- Males and females of reproductive potential may not participate unless they have
agreed to use an effective contraceptive method
- Lactating females may not participate unless they have agreed not to breastfeed a
child while on this study
Intervention(s):
other: clinical observation
radiation: 3-dimensional conformal radiation therapy
drug: cisplatin
drug: cyclophosphamide
drug: etoposide
drug: carboplatin
other: laboratory biomarker analysis
drug: Vincristine
biological: Filgrastim
drug: Mesna
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Leah White
650-725-4708