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Etoposide Plus Cisplatin in Treating Patients With Recurrent Ependymomas

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cisplatin
etoposide
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent adult brain tumor, adult myxopapillary ependymoma, adult anaplastic ependymoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic Scottsdale
  • Mayo Clinic Jacksonville
  • Mayo Clinic Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
May 10, 2011
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002876
Brief Title
Etoposide Plus Cisplatin in Treating Patients With Recurrent Ependymomas
Official Title
A PHASE II TRIAL OF ETOPOSIDE AND CISPLATIN IN THE TREATMENT OF RECURRENT EPENDYMOMAS
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
October 1991 (undefined)
Primary Completion Date
April 1998 (Actual)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
recurrent adult brain tumor, adult myxopapillary ependymoma, adult anaplastic ependymoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
etoposide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randolph S. Marks, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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Etoposide Plus Cisplatin in Treating Patients With Recurrent Ependymomas

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