S9811 Hydroxyurea in Treating Patients With Unresectable Benign Meningioma
- Registration Number
- NCT00003590
- Lead Sponsor
- SWOG Cancer Research Network
- 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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hydroxyurea hydroxyurea -
- Primary Outcome Measures
Name Time Method Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR) Patients treated for 2 years or progression. If responding can continue at physician's discretion. 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).
- Secondary Outcome Measures
Name Time Method 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 Adverse Events (AEs) are reported by CTC 2.0 terminology. For each patient, worst grade of each event type is reported. Grade 3 - Severe, Grade 4 - Life-threatening, Grade 5 - Fatal
Trial Locations
- Locations (133)
Graham Hospital
🇺🇸Canton, Illinois, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
St. Anthony North Hospital
🇺🇸Westminster, Colorado, United States
Montrose Memorial Hospital Cancer Center
🇺🇸Montrose, Colorado, United States
M.D. Anderson Cancer Center - Orlando
🇺🇸Orlando, Florida, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
University of Illinois Medical Center
🇺🇸Chicago, Illinois, United States
Eureka Hospital
🇺🇸Eureka, Illinois, United States
Veterans Affairs Medical Center - Chicago Westside Hospital
🇺🇸Chicago, 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
Joliet Oncology Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
Hopedale Medical Complex
🇺🇸Hopedale, Illinois, United States
Kewanee Hospital
🇺🇸Kewanee, Illinois, United States
Edward Hospital Cancer Center
🇺🇸Naperville, Illinois, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois - Ottawa
🇺🇸Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
Oncology/Hematology Associates of Central Illinois, P.C.
🇺🇸Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
St. Margaret's Hospital
🇺🇸Spring Valley, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Valley Cancer Center
🇺🇸Spring Valley, 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 - Newton
🇺🇸Newton, Kansas, United States
Cancer Center of Kansas - Kingman
🇺🇸Kingman, Kansas, United States
Pratt Cancer Center of Kansas
🇺🇸Pratt, Kansas, United States
Cancer Center of Kansas, P.A. - Parsons
🇺🇸Parsons, Kansas, United States
Cancer Center of Kansas - Salina
🇺🇸Salina, Kansas, United States
Cancer Center of Kansas, P.A. - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Mary Bird Perkins Cancer Center - Baton Rouge
🇺🇸Baton Rouge, Louisiana, United States
DeCesaris Cancer Institute at Anne Arundel Medical Center
🇺🇸Annapolis, Maryland, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
🇺🇸Robbinsdale, Minnesota, United States
United Hospital
🇺🇸Saint Paul, Minnesota, United States
Park Nicollet Clinic
🇺🇸St. Louis Park, Minnesota, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
Veterans Affairs Medical Center - Kansas City
🇺🇸Kansas City, Missouri, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Great Falls Clinic
🇺🇸Great Falls, Montana, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
Adena Regional Medical Center
🇺🇸Chillicothe, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, 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
Community Hospital of Springfield and Clark County
🇺🇸Springfield, 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
Rose Ramer Cancer Clinic at Anderson Area Medical Center
🇺🇸Anderson, South Carolina, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Avera McKennan Hospital and University Health Center
🇺🇸Sioux Falls, South Dakota, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Medical X-Ray Center
🇺🇸Sioux Falls, South Dakota, 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
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
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
Olympic Medical Center
🇺🇸Port Angeles, Washington, United States
Good Samaritan Cancer Center
🇺🇸Puyallup, Washington, United States
Providence St. Peter Hospital Regional Cancer Center
🇺🇸Olympia, Washington, United States
Valley Medical Center
🇺🇸Renton, Washington, United States
St. Joseph Medical Center at Franciscan Health System
🇺🇸Tacoma, Washington, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
Allenmore Hospital
🇺🇸Tacoma, Washington, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
🇺🇸Fairbanks, Alaska, United States
North Idaho Cancer Center
🇺🇸Coeur d'Alene, Idaho, United States
Baton Rouge General Regional Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Sioux Valley Hospital and University of South Dakota Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Logan Regional Hospital
🇺🇸Logan, Utah, United States
Dixie Regional Medical Center
🇺🇸Saint George, Utah, United States
Camden-Clark Memorial Hospital
🇺🇸Parkersburg, West Virginia, United States
Cancer Center of Kansas - Ottawa
🇺🇸Ottawa, Kansas, United States
Cancer Center of Kansas - Chanute
🇺🇸Chanute, Kansas, United States
Associates in Womens Health
🇺🇸Wichita, Kansas, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas - Wellington
🇺🇸Wellington, Kansas, United States
Exempla Lutheran Medical Center
🇺🇸Wheat Ridge, Colorado, United States
Cancer Center of Kansas - Winfield
🇺🇸Winfield, Kansas, United States
Mercy and Unity Cancer Center at Mercy and Unity Hospitals
🇺🇸Fridley, Minnesota, United States
Cancer Center of Kansas, P.A. - El Dorado
🇺🇸El Dorado, Kansas, United States
Salina Regional Health Center
🇺🇸Salina, Kansas, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Huntsman Cancer Institute at University of Utah
🇺🇸Salt Lake City, Utah, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
CCOP - Western Regional, Arizona
🇺🇸Phoenix, Arizona, 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
Josephine Ford Cancer Center at Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Cancer Center at Medical Center of Louisiana - New Orleans
🇺🇸New Orleans, Louisiana, United States