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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 AssociationUrbana, Illinois  61801
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Fairview Ridges HospitalBurnsville, Minnesota  55337
Fairview Southdale HospitalEdina, Minnesota  55435
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
St. Joseph's Hospital and Medical CenterPhoenix, Arizona  85001-2071
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
Methodist Medical Center of IllinoisPeoria, Illinois  61636
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
CCOP - GreenvilleGreenville, South Carolina  29615
Dixie Regional Medical CenterSaint George, Utah  84770
LDS HospitalSalt Lake City, Utah  84143
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
CCOP - NorthwestTacoma, Washington  98405-0986
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Camden-Clark Memorial HospitalParkersburg, West Virginia  26102
University of California Davis Cancer CenterSacramento, California  95817
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Great Falls ClinicGreat Falls, Montana  59405
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
North Idaho Cancer CenterCoeur d'Alene, Idaho  83814
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Siouxland Hematology-Oncology AssociatesSioux City, Iowa  51101
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, P.A. - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - KingmanKingman, Kansas  67068
Southwest Medical CenterLiberal, Kansas  67901
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas, P.A. - ParsonsParsons, Kansas  67357
Pratt Cancer Center of KansasPratt, Kansas  67124
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas, P.A. - WichitaWichita, Kansas  67214
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Mount Carmel West HospitalColumbus, Ohio  43222
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Mercy Medical Center Oncology UnitSpringfield, Ohio  45504
Avera McKennan Hospital and University Health CenterSioux Falls, South Dakota  57105
Medical X-Ray CenterSioux Falls, South Dakota  57105
American Fork HospitalAmerican Fork, Utah  84003
Logan Regional HospitalLogan, Utah  84321
Cottonwood Hospital Medical CenterMurray, Utah  84107
McKay-Dee Hospital CenterOgden, Utah  84403
Josephine Ford Cancer Center at Henry Ford Health SystemDetroit, Michigan  48202
University of Illinois Medical CenterChicago, Illinois  60612
Center for Cancer Prevention and Care at Scott and White ClinicTemple, Texas  76508
Oncology/Hematology Associates of Central Illinois, P.C.Peoria, Illinois  61602
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Veterans Affairs Medical Center - Chicago Westside HospitalChicago, Illinois  60612
M.D. Anderson Cancer Center - OrlandoOrlando, Florida  32806
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
InterCommunity Cancer Center of Western IllinoisGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
Edward Hospital Cancer CenterNaperville, Illinois  60540
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
Valley Cancer CenterSpring Valley, Illinois  61362
Salina Regional Health CenterSalina, Kansas  67401
Mary Bird Perkins Cancer Center - Baton RougeBaton Rouge, Louisiana  70809
Virginia Piper Cancer Institute at Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Medical CenterRobbinsdale, Minnesota  55422-2900
Fairbanks Cancer Treatment Center at Fairbanks Memorial HospitalFairbanks, Alaska  99701
St. Anthony Central HospitalDenver, Colorado  80204-1335
Denver Health Medical CenterDenver, Colorado  80204-4507
Montrose Memorial Hospital Cancer CenterMontrose, Colorado  81401
St. Anthony North HospitalWestminster, Colorado  80030
Exempla Lutheran Medical CenterWheat Ridge, Colorado  80033
Eureka HospitalEureka, Illinois  61530
Joliet Oncology Hematology Associates, Limited - WestJoliet, Illinois  60435
Oncology Hematology Associates of Central Illinois - OttawaOttawa, Illinois  61350
Cancer Center of Kansas - OttawaOttawa, Kansas  66067
Baton Rouge General Regional Cancer CenterBaton Rouge, Louisiana  70821
Cancer Center at Medical Center of Louisiana - New OrleansNew Orleans, Louisiana  70140-1015
DeCesaris Cancer Institute at Anne Arundel Medical CenterAnnapolis, Maryland  21401
Mercy HospitalCoon Rapids, Minnesota  55433
Mercy and Unity Cancer Center at Mercy and Unity HospitalsFridley, Minnesota  55432-2799
Park Nicollet ClinicSt. Louis Park, Minnesota  55416
Community Oncology Group - IndependenceIndependence, Ohio  44131
Rose Ramer Cancer Clinic at Anderson Area Medical CenterAnderson, South Carolina  29621
Grays Harbor Community HospitalAberdeen, Washington  98520
Auburn Regional Center for Cancer Care at Auburn Regional Medical CenterAuburn, Washington  98001-4908
St. Francis HospitalFederal Way, Washington  98003
Cascade Cancer Center at Evergreen Hospital Medical CenterKirkland, Washington  98034-3013
St. Clare HospitalLakewood, Washington  98499-0998
Capital Medical CenterOlympia, Washington  98502
Providence St. Peter Hospital Regional Cancer CenterOlympia, Washington  98506
Olympic Medical CenterPort Angeles, Washington  98362
Good Samaritan Cancer CenterPuyallup, Washington  98371
Valley Medical CenterRenton, Washington  98055
St. Joseph Medical Center at Franciscan Health SystemTacoma, Washington  98405-3004
Allenmore HospitalTacoma, Washington  98411-0414