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Phase II Study of Intravenous Etoposide in Patients With Relapsed Ependymoma


Phase 2
N/A
21 Years
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

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Trial Information

Phase II Study of Intravenous Etoposide in Patients With Relapsed Ependymoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate by MRI after course 3

Safety Issue:

No

Principal Investigator

Linda S. Lashford

Investigator Affiliation:

Christie Hospital NHS Foundation Trust

Authority:

Unspecified

Study ID:

CDR0000454543

NCT ID:

NCT00278252

Start Date:

July 2001

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent childhood ependymoma
  • childhood infratentorial ependymoma
  • childhood supratentorial ependymoma
  • Ependymoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

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