NCT00002876

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 1991

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1991

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 1998

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.6 years until next milestone

First Posted

Study publicly available on registry

May 21, 2004

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
Last Updated

May 11, 2011

Status Verified

May 1, 2011

Enrollment Period

6.5 years

First QC Date

November 1, 1999

Last Update Submit

May 10, 2011

Conditions

Keywords

recurrent adult brain tumoradult myxopapillary ependymomaadult anaplastic ependymoma

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsEpendymoma

Interventions

CisplatinEtoposide

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBrain DiseasesCentral Nervous System DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydrates

Study Officials

  • Randolph S. Marks, MD

    Mayo Clinic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

May 21, 2004

Study Start

October 1, 1991

Primary Completion

April 1, 1998

Study Completion

January 1, 2005

Last Updated

May 11, 2011

Record last verified: 2011-05

Locations