Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Younger Patients with Newly Diagnosed Ependymoma

Overview

About this study

This randomized phase III trial is studying maintenance chemotherapy to see how well it works compared to observation following induction chemotherapy and radiation therapy in treating young patients with newly diagnosed ependymoma. Drugs used in chemotherapy, 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 or by stopping them from dividing. 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 with radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Histologically confirmed intracranial ependymoma meeting the following criteria:
- Newly diagnosed disease
- Classic ependymoma (WHO II) or anaplastic ependymoma (WHO III), including the following subtypes:
  - Clear cell
  - Papillary
  - Cellular
  - Combination of the above
No diagnosis of spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed glioma
Has undergone surgical resection of the primary tumor
- More than 1 attempted resection allowed
No metastatic disease by MRI or cerebrospinal fluid (CSF) cytology
- CSR cytology from a ventriculostomy or permanent VP shunt that reveals the presence of tumor cells is indicative of metastatic disease
No evidence of non-contiguous spread beyond the primary site as determined by pre- or post-operative MRI of brain, pre- or post-operative MRI of the spine, and post-operative CSF cytology obtained from the lumbar CSF space
- Lumbar CSF examination may be waived if deemed to be medically contraindicated
ECOG performance status (PS) 0-2
- Karnofsky PS for patients > 16 years of age
- Lansky PS for patients ≤ 16 years of age
ANC ≥ 1,000/μL
Platelet count ≥ 100,000/μL (transfusion independent)
Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR serum creatinine based on age/gender as follows:
- 0.4 mg/dL (1 month to < 6 months of age)
- 0.5 mg/dL (6 months to < 1 year of age)
- 0.6 mg/dL (1 to 2 years of age)
- 0.8 mg/dL (2 to < 6 years of age)
- 1.0 mg/dL (6 to 10 years of age)
- 1.2 mg/dL (10 to 13 years of age)
- 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)
- 1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age)
Total bilirubin ≤ 1.5 times upper limit of normal (ULN) (≤ 3 times ULN for patients with Gilbert syndrome or hemolytic anemia)
AST or ALT < 3 times ULN
Adequate cardiac function defined as 1 of the following:
- Shortening fraction ≥ 27% by ECHO
- Ejection fraction ≥ 50% by gated radionuclide study.
Not pregnant or nursing
- Patients who agree to stop nursing while on this study are allowed
Negative pregnancy test
Fertile patients must use effective contraception
No prior treatment for ependymoma other than surgical intervention and corticosteroids

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Wendy Allen-Rhoades, M.D., Ph.D.	Closed for enrollment	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Wendy Allen-Rhoades, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Clinical Trials