Etoposide Plus Cisplatin in Treating Patients With Recurrent Ependymomas

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002876
• Other study ID #: CDR0000065162
• Secondary ID: P30CA01508390725
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: May 10, 2011
• Start date: October 1991
• Est. completion date: January 2005

Study information

• Verified date: May 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with recurrent ependymomas following radiation therapy.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2005
• Est. primary completion date: April 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Ependymoma
• Nervous System Neoplasms

Intervention

Drug:
• cisplatin

• etoposide

Locations

Country	Name	City	State
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Mayo Clinic Scottsdale	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,