S9811 Hydroxyurea in Treating Patients With Unresectable Benign Meningioma
NCT ID: NCT00003590
Last Updated: 2016-05-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
29 participants
INTERVENTIONAL
1998-11-30
2011-07-31
Brief Summary
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PURPOSE: This phase II trial is studying how well hydroxyurea works in treating patients with unresectable benign meningioma.
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Detailed Description
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* Determine the partial and complete response rates in patients with unresectable benign meningioma treated with hydroxyurea.
* Assess the quantitative and qualitative toxic effects of this drug in this patient population.
OUTLINE: Patients receive oral hydroxyurea twice daily for 2 years in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3 months, 6 months, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study within 13 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Hydroxyurea
hydroxyurea
20 mg/kg/day PO
Interventions
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hydroxyurea
20 mg/kg/day PO
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed unresectable primary, recurrent, or residual benign meningioma
* Measurable disease by CT scan or MRI
* Must have disease progression within the past 10 years OR progressive neurologic deficit within the past 6 months
* Must have undergone prior radiotherapy with subsequent disease progression OR refused radiotherapy
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* SWOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 4,000/mm\^3
* Platelet count at least lower limit of normal
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior cytotoxic chemotherapy for meningioma
* Prior mifepristone allowed
* No other concurrent chemotherapy
Endocrine therapy:
* Concurrent glucocorticoids and hormone replacement therapy allowed if stable dose maintained for at least 72 hours prior to CT scan or MRI
* No concurrent antitumor hormonal therapy
Radiotherapy:
* See Disease Characteristics
* At least 6 months since prior radiotherapy
* No concurrent radiotherapy
Surgery:
* Not specified
18 Years
120 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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Lode J. Swinnen, MD
Role: STUDY_CHAIR
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Geoffrey R. Barger, MD
Role: STUDY_CHAIR
Barbara Ann Karmanos Cancer Institute
Locations
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Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
Fairbanks, Alaska, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States
St. Anthony Central Hospital
Denver, Colorado, United States
Denver Health Medical Center
Denver, Colorado, United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States
Montrose Memorial Hospital Cancer Center
Montrose, Colorado, United States
St. Anthony North Hospital
Westminster, Colorado, United States
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States
M.D. Anderson Cancer Center - Orlando
Orlando, Florida, United States
North Idaho Cancer Center
Coeur d'Alene, Idaho, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, United States
St. Joseph Medical Center
Bloomington, Illinois, United States
Graham Hospital
Canton, Illinois, United States
Memorial Hospital
Carthage, Illinois, United States
University of Illinois Medical Center
Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago Westside Hospital
Chicago, Illinois, United States
Eureka Hospital
Eureka, Illinois, United States
Galesburg Clinic
Galesburg, Illinois, United States
Galesburg Cottage Hospital
Galesburg, Illinois, United States
InterCommunity Cancer Center of Western Illinois
Galesburg, Illinois, United States
Mason District Hospital
Havana, Illinois, United States
Hopedale Medical Complex
Hopedale, Illinois, United States
Joliet Oncology Hematology Associates, Limited - West
Joliet, Illinois, United States
Kewanee Hospital
Kewanee, Illinois, United States
McDonough District Hospital
Macomb, Illinois, United States
Edward Hospital Cancer Center
Naperville, Illinois, United States
BroMenn Regional Medical Center
Normal, Illinois, United States
Community Cancer Center
Normal, Illinois, United States
Community Hospital of Ottawa
Ottawa, Illinois, United States
Oncology Hematology Associates of Central Illinois - Ottawa
Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States
Proctor Hospital
Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
OSF St. Francis Medical Center
Peoria, Illinois, United States
Illinois Valley Community Hospital
Peru, Illinois, United States
Perry Memorial Hospital
Princeton, Illinois, United States
St. Margaret's Hospital
Spring Valley, Illinois, United States
Valley Cancer Center
Spring Valley, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States
Carle Clinic Association
Urbana, Illinois, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States
Siouxland Hematology-Oncology Associates
Sioux City, Iowa, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas, P.A. - El Dorado
El Dorado, Kansas, United States
Cancer Center of Kansas - Kingman
Kingman, Kansas, United States
Southwest Medical Center
Liberal, Kansas, United States
Cancer Center of Kansas - Newton
Newton, Kansas, United States
Cancer Center of Kansas - Ottawa
Ottawa, Kansas, United States
Cancer Center of Kansas, P.A. - Parsons
Parsons, Kansas, United States
Pratt Cancer Center of Kansas
Pratt, Kansas, United States
Cancer Center of Kansas - Salina
Salina, Kansas, United States
Salina Regional Health Center
Salina, Kansas, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States
Associates in Womens Health
Wichita, Kansas, United States
Cancer Center of Kansas, P.A. - Wichita
Wichita, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States
Baton Rouge General Regional Cancer Center
Baton Rouge, Louisiana, United States
Cancer Center at Medical Center of Louisiana - New Orleans
New Orleans, Louisiana, United States
DeCesaris Cancer Institute at Anne Arundel Medical Center
Annapolis, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Josephine Ford Cancer Center at Henry Ford Health System
Detroit, Michigan, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Mercy and Unity Cancer Center at Mercy and Unity Hospitals
Fridley, Minnesota, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Park Nicollet Clinic
Saint Louis Park, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States
Mount Carmel West Hospital
Columbus, Ohio, United States
Doctors Hospital at Ohio Health
Columbus, Ohio, United States
Grady Memorial Hospital
Delaware, Ohio, United States
Community Oncology Group - Independence
Independence, Ohio, United States
Fairfield Medical Center
Lancaster, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States
Mercy Medical Center Oncology Unit
Springfield, Ohio, United States
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States
Rose Ramer Cancer Clinic at Anderson Area Medical Center
Anderson, South Carolina, United States
CCOP - Greenville
Greenville, South Carolina, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, United States
Medical X-Ray Center
Sioux Falls, South Dakota, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States
Center for Cancer Prevention and Care at Scott and White Clinic
Temple, Texas, United States
American Fork Hospital
American Fork, Utah, United States
Logan Regional Hospital
Logan, Utah, United States
Cottonwood Hospital Medical Center
Murray, Utah, United States
McKay-Dee Hospital Center
Ogden, Utah, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
Dixie Regional Medical Center
St. George, Utah, United States
Grays Harbor Community Hospital
Aberdeen, Washington, United States
Auburn Regional Center for Cancer Care at Auburn Regional Medical Center
Auburn, Washington, United States
St. Francis Hospital
Federal Way, Washington, United States
Cascade Cancer Center at Evergreen Hospital Medical Center
Kirkland, Washington, United States
St. Clare Hospital
Lakewood, Washington, United States
Capital Medical Center
Olympia, Washington, United States
Providence St. Peter Hospital Regional Cancer Center
Olympia, Washington, United States
Olympic Medical Center
Port Angeles, Washington, United States
Good Samaritan Cancer Center
Puyallup, Washington, United States
Valley Medical Center
Renton, Washington, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, United States
CCOP - Northwest
Tacoma, Washington, United States
St. Joseph Medical Center at Franciscan Health System
Tacoma, Washington, United States
Allenmore Hospital
Tacoma, Washington, United States
Camden-Clark Memorial Hospital
Parkersburg, West Virginia, United States
Countries
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References
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Swinnen LJ, Rankin C, Rushing EJ, et al.: Phase II study of hydroxyurea for unresectable meningioma (Southwest Oncology Group S9811). [Abstract] J Clin Oncol 27 (Suppl 15): A-2063, 2009.
Other Identifiers
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S9811
Identifier Type: OTHER
Identifier Source: secondary_id
ECOG-S9811
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000066659
Identifier Type: -
Identifier Source: org_study_id
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