Phase II Study of Hydroxyurea for Unresectable Meningioma
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
No
Lode J. Swinnen, MD
Study Chair
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
CDR0000066659
NCT00003590
November 1998
July 2011
Name | Location |
---|---|
Carle Clinic Association | Urbana, Illinois 61801 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
St. Joseph's Hospital and Medical Center | Phoenix, Arizona 85001-2071 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Columbus | Columbus, Ohio 43206 |
CCOP - Greenville | Greenville, South Carolina 29615 |
Dixie Regional Medical Center | Saint George, Utah 84770 |
LDS Hospital | Salt Lake City, Utah 84143 |
CCOP - Western Regional, Arizona | Phoenix, Arizona 85006-2726 |
University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
Veterans Affairs Medical Center - Kansas City | Kansas City, Missouri 64128 |
Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
CCOP - Northwest | Tacoma, Washington 98405-0986 |
Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
Camden-Clark Memorial Hospital | Parkersburg, West Virginia 26102 |
University of California Davis Cancer Center | Sacramento, California 95817 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
Great Falls Clinic | Great Falls, Montana 59405 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
North Idaho Cancer Center | Coeur d'Alene, Idaho 83814 |
Wilford Hall Medical Center | Lackland Air Force Base, Texas 78236-5300 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Siouxland Hematology-Oncology Associates | Sioux City, Iowa 51101 |
Cancer Center of Kansas - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, P.A. - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas - Kingman | Kingman, Kansas 67068 |
Southwest Medical Center | Liberal, Kansas 67901 |
Cancer Center of Kansas - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, P.A. - Parsons | Parsons, Kansas 67357 |
Pratt Cancer Center of Kansas | Pratt, Kansas 67124 |
Cancer Center of Kansas - Salina | Salina, Kansas 67042 |
Cancer Center of Kansas - Wellington | Wellington, Kansas 67152 |
Associates in Womens Health | Wichita, Kansas 67203 |
Cancer Center of Kansas, P.A. - Wichita | Wichita, Kansas 67214 |
Cancer Center of Kansas - Winfield | Winfield, Kansas 67156 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Mount Carmel West Hospital | Columbus, Ohio 43222 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
Mercy Medical Center Oncology Unit | Springfield, Ohio 45504 |
Avera McKennan Hospital and University Health Center | Sioux Falls, South Dakota 57105 |
Medical X-Ray Center | Sioux Falls, South Dakota 57105 |
American Fork Hospital | American Fork, Utah 84003 |
Logan Regional Hospital | Logan, Utah 84321 |
Cottonwood Hospital Medical Center | Murray, Utah 84107 |
McKay-Dee Hospital Center | Ogden, Utah 84403 |
Josephine Ford Cancer Center at Henry Ford Health System | Detroit, Michigan 48202 |
University of Illinois Medical Center | Chicago, Illinois 60612 |
Center for Cancer Prevention and Care at Scott and White Clinic | Temple, Texas 76508 |
Oncology/Hematology Associates of Central Illinois, P.C. | Peoria, Illinois 61602 |
Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
Veterans Affairs Medical Center - Chicago Westside Hospital | Chicago, Illinois 60612 |
M.D. Anderson Cancer Center - Orlando | Orlando, Florida 32806 |
St. Joseph Medical Center | Bloomington, Illinois 61701 |
Graham Hospital | Canton, Illinois 61520 |
Memorial Hospital | Carthage, Illinois 62321 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
Galesburg Clinic | Galesburg, Illinois 61401 |
InterCommunity Cancer Center of Western Illinois | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
Hopedale Medical Complex | Hopedale, Illinois 61747 |
Kewanee Hospital | Kewanee, Illinois 61443 |
McDonough District Hospital | Macomb, Illinois 61455 |
Edward Hospital Cancer Center | Naperville, Illinois 60540 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
Proctor Hospital | Peoria, Illinois 61614 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
St. Margaret's Hospital | Spring Valley, Illinois 61362 |
Valley Cancer Center | Spring Valley, Illinois 61362 |
Salina Regional Health Center | Salina, Kansas 67401 |
Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge, Louisiana 70809 |
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Hubert H. Humphrey Cancer Center at North Memorial Medical Center | Robbinsdale, Minnesota 55422-2900 |
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital | Fairbanks, Alaska 99701 |
St. Anthony Central Hospital | Denver, Colorado 80204-1335 |
Denver Health Medical Center | Denver, Colorado 80204-4507 |
Montrose Memorial Hospital Cancer Center | Montrose, Colorado 81401 |
St. Anthony North Hospital | Westminster, Colorado 80030 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
Eureka Hospital | Eureka, Illinois 61530 |
Joliet Oncology Hematology Associates, Limited - West | Joliet, Illinois 60435 |
Oncology Hematology Associates of Central Illinois - Ottawa | Ottawa, Illinois 61350 |
Cancer Center of Kansas - Ottawa | Ottawa, Kansas 66067 |
Baton Rouge General Regional Cancer Center | Baton Rouge, Louisiana 70821 |
Cancer Center at Medical Center of Louisiana - New Orleans | New Orleans, Louisiana 70140-1015 |
DeCesaris Cancer Institute at Anne Arundel Medical Center | Annapolis, Maryland 21401 |
Mercy Hospital | Coon Rapids, Minnesota 55433 |
Mercy and Unity Cancer Center at Mercy and Unity Hospitals | Fridley, Minnesota 55432-2799 |
Park Nicollet Clinic | St. Louis Park, Minnesota 55416 |
Community Oncology Group - Independence | Independence, Ohio 44131 |
Rose Ramer Cancer Clinic at Anderson Area Medical Center | Anderson, South Carolina 29621 |
Grays Harbor Community Hospital | Aberdeen, Washington 98520 |
Auburn Regional Center for Cancer Care at Auburn Regional Medical Center | Auburn, Washington 98001-4908 |
St. Francis Hospital | Federal Way, Washington 98003 |
Cascade Cancer Center at Evergreen Hospital Medical Center | Kirkland, Washington 98034-3013 |
St. Clare Hospital | Lakewood, Washington 98499-0998 |
Capital Medical Center | Olympia, Washington 98502 |
Providence St. Peter Hospital Regional Cancer Center | Olympia, Washington 98506 |
Olympic Medical Center | Port Angeles, Washington 98362 |
Good Samaritan Cancer Center | Puyallup, Washington 98371 |
Valley Medical Center | Renton, Washington 98055 |
St. Joseph Medical Center at Franciscan Health System | Tacoma, Washington 98405-3004 |
Allenmore Hospital | Tacoma, Washington 98411-0414 |