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A PHASE II TRIAL OF ETOPOSIDE AND CISPLATIN IN THE TREATMENT OF RECURRENT EPENDYMOMAS


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

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Trial Information

A PHASE II TRIAL OF ETOPOSIDE AND CISPLATIN IN THE TREATMENT OF RECURRENT EPENDYMOMAS


OBJECTIVES: I. Assess the efficacy and toxicity of etoposide and cisplatin in patients with
recurrent ependymomas.

OUTLINE: All patients receive cisplatin followed by etoposide on days 1-3. Treatment repeats
every 4 weeks for a total of 6 courses unless disease progression or unacceptable toxicity
intervenes. The etoposide dose may be increased by 10% on subsequent courses if the white
blood cell and platelet nadirs on the previous course are at least 3,000 and 100,000,
respectively. Patients are followed every 2 months for 6 months, then every 3 months for 4.5
years.

PROJECTED ACCRUAL: A total of 35 patients will be entered over approximately 7 years if
there are 3-8 responses in the first 13 patients and 7-9 responses in the first 25 patients.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed ependymoma that is recurrent after
radiotherapy Histologic confirmation of recurrence encouraged but not required in patients
with pure ependymoma at diagnosis and unequivocal radiologic evidence of recurrence
Histologic confirmation of recurrence required in patients with mixed histology at
diagnosis Ependymoma at least 80% of histology No subependymoma Measurable or evaluable
disease on imaging exam

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Hematopoietic: WBC
at least 3,500 Platelets at least 130,000 Hepatic: Bilirubin no greater than 0.3 mg/dL
above normal Renal: Creatinine no greater than 0.3 mg/dL above normal Cardiovascular: No
NYHA class III/IV status Other: No uncontrolled infection No pregnant or nursing women
Negative pregnancy test required of fertile women Effective contraception required of
fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cisplatin
or etoposide At least 4 weeks since chemotherapy (6 weeks since nitrosoureas) Endocrine
therapy: Steroid dose stable for at least 1 week prior to entry if indicator lesion in CNS
Radiotherapy: See Disease Characteristics At least 4 weeks since radiotherapy Surgery: Not
specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Randolph S. Marks, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000065162

NCT ID:

NCT00002876

Start Date:

October 1991

Completion Date:

January 2005

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult myxopapillary ependymoma
  • adult anaplastic ependymoma
  • Ependymoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Mayo Clinic JacksonvilleJacksonville, Florida  32224