S9811 Hydroxyurea in Treating Patients With Unresectable Benign Meningioma
Phase II Study of Hydroxyurea for Unresectable Meningioma
4 other identifiers
interventional
29
1 country
133
Brief Summary
RATIONALE: Drugs used in chemotherapy such as hydroxyurea use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well hydroxyurea works in treating patients with unresectable benign meningioma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 1998
Longer than P75 for phase_2
133 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
February 16, 2012
CompletedMay 20, 2016
April 1, 2016
10.1 years
November 1, 1999
November 7, 2011
April 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)
Complete Response (CR)is a complete disappearance of all measurable and evaluable disease. No new lesions, no disease related symptoms, no evidence of non-evaluable disease. Partial Response (PR)is greater than or equal to 50% decrease under baseline in sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease, no new lesions. Confirmation of CR or PR means a repeat scan at least 3 weeks apart documented before progression. No response means that patient did not achieve complete or partial response (either confirmed or unconfirmed).
Patients treated for 2 years or progression. If responding can continue at physician's discretion.
Secondary Outcomes (1)
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug
Patients were assessed for adverse events 4 weeks after starting treatment. Assessments for adverse events continued every 3 months for the duration of protocol therapy. On average patients remained on therapy for 8 months
Study Arms (1)
Hydroxyurea
EXPERIMENTALInterventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- SWOG Cancer Research Networklead
- National Cancer Institute (NCI)collaborator
- Eastern Cooperative Oncology Groupcollaborator
Study Sites (133)
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85001-2071, United States
CCOP - Western Regional, Arizona
Phoenix, Arizona, 85006-2726, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000, United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305, United States
University of California Davis Cancer Center
Sacramento, California, 95817, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, 80010, United States
St. Anthony Central Hospital
Denver, Colorado, 80204-1335, United States
Denver Health Medical Center
Denver, Colorado, 80204-4507, United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220, United States
Montrose Memorial Hospital Cancer Center
Montrose, Colorado, 81401, United States
St. Anthony North Hospital
Westminster, Colorado, 80030, United States
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, 80033, United States
M.D. Anderson Cancer Center - Orlando
Orlando, Florida, 32806-2134, United States
North Idaho Cancer Center
Coeur d'Alene, Idaho, 83814, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, 60504-4206, United States
St. Joseph Medical Center
Bloomington, Illinois, 61701, United States
Graham Hospital
Canton, Illinois, 61520, United States
Memorial Hospital
Carthage, Illinois, 62321, United States
University of Illinois Medical Center
Chicago, Illinois, 60612, United States
Veterans Affairs Medical Center - Chicago Westside Hospital
Chicago, Illinois, 60612, United States
Eureka Hospital
Eureka, Illinois, 61530, United States
Galesburg Clinic
Galesburg, Illinois, 61401, United States
Galesburg Cottage Hospital
Galesburg, Illinois, 61401, United States
InterCommunity Cancer Center of Western Illinois
Galesburg, Illinois, 61401, United States
Mason District Hospital
Havana, Illinois, 62644, United States
Hopedale Medical Complex
Hopedale, Illinois, 61747, United States
Joliet Oncology Hematology Associates, Limited - West
Joliet, Illinois, 60435, United States
Kewanee Hospital
Kewanee, Illinois, 61443, United States
McDonough District Hospital
Macomb, Illinois, 61455, United States
Edward Hospital Cancer Center
Naperville, Illinois, 60540, United States
BroMenn Regional Medical Center
Normal, Illinois, 61761, United States
Community Cancer Center
Normal, Illinois, 61761, United States
Community Hospital of Ottawa
Ottawa, Illinois, 61350, United States
Oncology Hematology Associates of Central Illinois - Ottawa
Ottawa, Illinois, 61350, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, 61554, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61615-7828, United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61615-7828, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF St. Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois Valley Community Hospital
Peru, Illinois, 61354, United States
Perry Memorial Hospital
Princeton, Illinois, 61356, United States
St. Margaret's Hospital
Spring Valley, Illinois, 61362, United States
Valley Cancer Center
Spring Valley, Illinois, 61362, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Carle Clinic Association
Urbana, Illinois, 61801, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, 46360-4358, United States
Siouxland Hematology-Oncology Associates
Sioux City, Iowa, 51101-1733, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51101, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas, P.A. - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Kingman
Kingman, Kansas, 67068, United States
Southwest Medical Center
Liberal, Kansas, 67901, United States
Cancer Center of Kansas - Newton
Newton, Kansas, 67114, United States
Cancer Center of Kansas - Ottawa
Ottawa, Kansas, 66067, United States
Cancer Center of Kansas, P.A. - Parsons
Parsons, Kansas, 67357, United States
Pratt Cancer Center of Kansas
Pratt, Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina, Kansas, 67401, United States
Salina Regional Health Center
Salina, Kansas, 67401, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152, United States
Associates in Womens Health
Wichita, Kansas, 67203, United States
Cancer Center of Kansas, P.A. - Wichita
Wichita, Kansas, 67214-3728, United States
CCOP - Wichita
Wichita, Kansas, 67214-3882, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156, United States
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, 70809, United States
Baton Rouge General Regional Cancer Center
Baton Rouge, Louisiana, 70821, United States
Cancer Center at Medical Center of Louisiana - New Orleans
New Orleans, Louisiana, 70140-1015, United States
DeCesaris Cancer Institute at Anne Arundel Medical Center
Annapolis, Maryland, 21401, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231, United States
Josephine Ford Cancer Center at Henry Ford Health System
Detroit, Michigan, 48202, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Mercy and Unity Cancer Center at Mercy and Unity Hospitals
Fridley, Minnesota, 55432-2799, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, 55422-2900, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Clinic
Saint Louis Park, Minnesota, 55416, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505, United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128, United States
CCOP - Kansas City
Kansas City, Missouri, 64131, United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101, United States
Great Falls Clinic
Great Falls, Montana, 59403, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195-9001, United States
CCOP - Columbus
Columbus, Ohio, 43206, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, 43214-3998, United States
Mount Carmel West Hospital
Columbus, Ohio, 43222, United States
Doctors Hospital at Ohio Health
Columbus, Ohio, 43228, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Community Oncology Group - Independence
Independence, Ohio, 44131, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, 45750-1635, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, 43055-2899, United States
Mercy Medical Center Oncology Unit
Springfield, Ohio, 45501, United States
Community Hospital of Springfield and Clark County
Springfield, Ohio, 45505, United States
Rose Ramer Cancer Clinic at Anderson Area Medical Center
Anderson, South Carolina, 29621, United States
CCOP - Greenville
Greenville, South Carolina, 29615, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, 57104, United States
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, 57105-1080, United States
Medical X-Ray Center
Sioux Falls, South Dakota, 57105, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234-6200, United States
Wilford Hall Medical Center
Lackland Air Force Base, Texas, 78236-5300, United States
Center for Cancer Prevention and Care at Scott and White Clinic
Temple, Texas, 76508, United States
American Fork Hospital
American Fork, Utah, 84003, United States
Logan Regional Hospital
Logan, Utah, 84341, United States
Cottonwood Hospital Medical Center
Murray, Utah, 84107, United States
McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, 84604, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112-5550, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Dixie Regional Medical Center
St. George, Utah, 84770, United States
Grays Harbor Community Hospital
Aberdeen, Washington, 98520, United States
Auburn Regional Center for Cancer Care at Auburn Regional Medical Center
Auburn, Washington, 98001-4908, United States
St. Francis Hospital
Federal Way, Washington, 98003, United States
Cascade Cancer Center at Evergreen Hospital Medical Center
Kirkland, Washington, 98034-3013, United States
St. Clare Hospital
Lakewood, Washington, 98499-0998, United States
Capital Medical Center
Olympia, Washington, 98502, United States
Providence St. Peter Hospital Regional Cancer Center
Olympia, Washington, 98506, United States
Olympic Medical Center
Port Angeles, Washington, 98362, United States
Good Samaritan Cancer Center
Puyallup, Washington, 98371, United States
Valley Medical Center
Renton, Washington, 98055, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101, United States
CCOP - Northwest
Tacoma, Washington, 98405-0986, United States
St. Joseph Medical Center at Franciscan Health System
Tacoma, Washington, 98405-3004, United States
Allenmore Hospital
Tacoma, Washington, 98411-0414, United States
Camden-Clark Memorial Hospital
Parkersburg, West Virginia, 26102, United States
Related Publications (1)
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.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Early termination leading to fewer than expected subjects analyzed. With 28 eligible patients estimate of response probability can be estimated to within +/- 19%.
Results Point of Contact
- Title
- Study Statistician
- Organization
- SWOG Statistical Center
Study Officials
- STUDY CHAIR
Lode J. Swinnen, MD
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- STUDY CHAIR
Geoffrey R. Barger, MD
Barbara Ann Karmanos Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 1999
First Posted
January 27, 2003
Study Start
November 1, 1998
Primary Completion
December 1, 2008
Study Completion
July 1, 2011
Last Updated
May 20, 2016
Results First Posted
February 16, 2012
Record last verified: 2016-04