S9624 Ifosfamide in Treating Patients With Meningeal Tumors
NCT ID: NCT00003292
Last Updated: 2013-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
7 participants
INTERVENTIONAL
1998-07-31
2004-01-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of ifosfamide in treating patients with meningeal tumors that have recurred or that cannot be removed surgically.
Detailed Description
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* Estimate failure free survival, overall survival, and response in patients with residual or recurrent/progressive aggressive meningeal tumors (malignant meningioma, hemangiopericytoma, and primary nervous system sarcoma) treated with ifosfamide.
* Evaluate toxicities of ifosfamide in this patient population.
OUTLINE: All patients receive ifosfamide IV continuously over 72 hours on days 1-3 of each 21 day treatment course. Patients are evaluated for response/progression after every 2 courses. Patients with stable disease receive up to 8 courses of therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year, then every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 35 patients will be accrued for this study.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ifosfamide
ifosfamide
ifosfamide
Interventions
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ifosfamide
Eligibility Criteria
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Inclusion Criteria
* Histologically proven recurrent or unresectable:
* Malignant meningioma
* Intracranial hemangiopericytoma
* Primary central nervous system sarcoma, including:
* Fibrosarcoma
* Rhabdomyosarcoma
* Chondrosarcoma
* Leiomyosarcoma
* Measurable or evaluable disease on CT or MRI scan
* Persistent disease following biopsy or incomplete resection OR
* Recurrent disease following complete resection
* No benign meningioma
* No prior or current systemic sarcoma
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* SWOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 3,000/mm\^3
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Not specified
Renal:
* Creatinine no greater than 2.0 mg/dL
Cardiovascular:
* No myocardial infarction within the past 3 months
* No active angina
* No unstable heart rhythms
* No congestive heart failure
Other:
* HIV negative
* No allergy to study drugs
* No serious concurrent medical or psychiatric illness
* No uncontrolled peptic ulcer disease
* No prior malignancy within past 5 years except adequately treated:
* Basal or squamous cell carcinoma of the skin
* Carcinoma in situ of the cervix
* Not pregnant or nursing
* Effective contraception required of fertile patients
PRIOR CONCURRENT THERAPY:
* Recovered from toxic effects of prior therapy and/or from postoperative complications
Biologic therapy:
* Not specified
Chemotherapy:
* No prior ifosfamide
* No other concurrent chemotherapy
Endocrine therapy:
* No concurrent hormonal therapy (except estrogen replacement therapy)
* Corticosteroids allowed if dose is stable or decreasing
Radiotherapy:
* At least 4 weeks since prior radiotherapy
* Progressive disease following radiation required
* No concurrent radiotherapy
Surgery:
* See Disease Characteristics
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Leslie McAllister, MD
Role: STUDY_CHAIR
Neurological Clinic
Lynn G. Feun, MD
Role: STUDY_CHAIR
University of Miami Sylvester Comprehensive Cancer Center
Locations
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CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, United States
Stanford University Medical Center
Stanford, California, United States
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Veterans Affairs Medical Center - Gainesville
Gainesville, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States
CCOP - Central Illinois
Decatur, Illinois, United States
CCOP - Evanston
Evanston, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
Mercy Medical Center
Des Moines, Iowa, United States
Iowa Lutheran Hospital
Des Moines, Iowa, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Tuft-New England Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Alegent Health-Midlands Community Hospital
Papillion, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, United States
Veterans Affairs Medical Center - New York
New York, New York, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States
James P. Wilmot Cancer Center
Rochester, New York, United States
Albert Einstein Clinical Cancer Center
The Bronx, New York, United States
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
CCOP - Oklahoma
Tulsa, Oklahoma, United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Drexel University Hospital
Philadelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh, Pennsylvania, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States
Westmead Hospital
Westmead, New South Wales, Australia
Instituto de Enfermedades Neoplasicas
Lima, , Peru
MBCCOP - San Juan
San Juan, , Puerto Rico
Veterans Affairs Medical Center - San Juan
San Juan, , Puerto Rico
San Juan City Hospital
San Juan, , Puerto Rico
Countries
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Other Identifiers
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S9624
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000066225
Identifier Type: -
Identifier Source: org_study_id