Etoposide Plus Cisplatin in Treating Patients With Recurrent Ependymomas

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00002876
First received: November 1, 1999
Last updated: May 10, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: cisplatin
Drug: etoposide
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A PHASE II TRIAL OF ETOPOSIDE AND CISPLATIN IN THE TREATMENT OF RECURRENT EPENDYMOMAS

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Estimated Enrollment: 35
Study Start Date: October 1991
Study Completion Date: January 2005
Primary Completion Date: April 1998 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002876

Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Randolph S. Marks, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Randolph S. Marks, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00002876     History of Changes
Other Study ID Numbers: CDR0000065162, P30CA015083, 907253, V96-1072, 394-91
Study First Received: November 1, 1999
Last Updated: May 10, 2011
Health Authority: United States: Federal Government

Keywords provided by Mayo Clinic:
recurrent adult brain tumor
adult myxopapillary ependymoma
adult anaplastic ependymoma

Additional relevant MeSH terms:
Ependymoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Etoposide phosphate
Cisplatin
Etoposide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014