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Phase II Study of Hydroxyurea for Unresectable Meningioma


Phase 2
18 Years
N/A
Not Enrolling
Both
Adult Meningioma

Thank you

Trial Information

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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)

Outcome Description:

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).

Outcome Time Frame:

Patients treated for 2 years or progression. If responding can continue at physician's discretion.

Safety Issue:

No

Principal Investigator

Lode J. Swinnen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066659

NCT ID:

NCT00003590

Start Date:

November 1998

Completion Date:

July 2011

Related Keywords:

  • Adult Meningioma
  • recurrent adult brain tumor
  • adult grade I meningioma
  • Meningioma

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