Clinical trial NCT00278252: Etoposide in Treating Young Patients With Relapsed Ependymoma
Official title: Phase II Study of Intravenous Etoposide in Patients With Relapsed Ependymoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Brain and Central Nervous System Tumors
Keywords: recurrent childhood ependymoma
childhood infratentorial ependymoma
childhood supratentorial ependymoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-01-18
Enrollment: 14
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy, such as etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well etoposide works in treating young patients with ependymoma.

Detailed description: OBJECTIVES:

Primary

* Determine the response rate in young patients with relapsing and/or refractory ependymoma treated with a rapid schedule of intravenous etoposide.

Secondary

* Determine the possibility of second surgery or additional radiotherapy in these patients.

OUTLINE: This is a multicenter study.

Patients receive etoposide IV over 1 hour on days 1-3, 8-10, and 15-17. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients whose tumor becomes resectable after courses 3 or 6 undergo surgical resection.

After completion of study treatment, patients are followed periodically for approximately 5 years.

PROJECTED ACCRUAL: At least 14 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed intracranial ependymoma at first, second, or third relapse

  * Anaplastic (malignant) or low-grade ependymoma (cellular, papillary, clear cell, or mixed variants)
* Unequivocal evidence of tumor recurrence or progression by MRI scan after failing conventional treatment (e.g., primary surgery and adjuvant radiotherapy) for initial or recurrent disease
* Unresectable disease OR not amenable to complete surgical resection
* Measurable enhancing or non-enhancing disease on baseline scan performed within the past 2 weeks

  * Patients who have undergone prior surgery must have residual measurable disease

PATIENT CHARACTERISTICS:

* Lansky performance status 30-100%
* Life expectancy ≥ 8 weeks
* Absolute neutrophil count \> 1,000/mm\^3
* Platelet count \> 100,000/mm\^3
* Serum total bilirubin normal
* AST \< 2 times upper limit of normal
* No unrelated medical condition (e.g., renal or liver impairment) that would preclude chemotherapy treatment
* No active infection
* No known HIV positivity

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No radiotherapy within the past 6 weeks
* No chemotherapy within the past 4 weeks
* Prior IV etoposide allowed

Primary outcomes:
measure: Response rate by MRI after course 3
Secondary outcomes:
measure: Second surgery or additional radiotherapy in responding patients as assessed by MRI scan after course 3 or 6
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Cancer Centre at St. James's University Hospital
state: England
Study officials:
affiliation: The Christie NHS Foundation Trust
name: Linda S. Lashford
affiliation: Leeds Cancer Centre at St. James's University Hospital
name: Susan V. Picton, MD
role: STUDY_CHAIR
References:
citation: Apps JR, Maycock S, Ellison DW, Jaspan T, Ritzmann TA, Macarthur D, Mallucci C, Wheatley K, Veal GJ, Grundy RG, Picton S. Phase II study of intravenous etoposide in patients with relapsed ependymoma (CNS 2001 04). Neurooncol Adv. 2022 Apr 13;4(1):vdac053. doi: 10.1093/noajnl/vdac053. eCollection 2022 Jan-Dec.