S9811 Hydroxyurea in Treating Patients With Unresectable Benign Meningioma

Adult Meningioma Clinical Trial

Official title:

Phase II Study of Hydroxyurea for Unresectable Meningioma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003590
• Other study ID #: CDR0000066659
• Secondary ID: S9811ECOG-S9811U
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: September 28, 2015
• Start date: November 1998
• Est. completion date: July 2011

Study information

• Verified date: September 2015
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: July 2011
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Adult Meningioma
• Meningioma

Intervention

Drug:
• hydroxyurea
20 mg/kg/day PO

Locations

Country	Name	City	State
United States	Grays Harbor Community Hospital	Aberdeen	Washington
United States	American Fork Hospital	American Fork	Utah
United States	Rose Ramer Cancer Clinic at Anderson Area Medical Center	Anderson	South Carolina
United States	DeCesaris Cancer Institute at Anne Arundel Medical Center	Annapolis	Maryland
United States	Auburn Regional Center for Cancer Care at Auburn Regional Medical Center	Auburn	Washington
United States	Rush-Copley Cancer Care Center	Aurora	Illinois
United States	University of Colorado Cancer Center at University of Colorado Health Sciences Center	Aurora	Colorado
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Baton Rouge General Regional Cancer Center	Baton Rouge	Louisiana
United States	Mary Bird Perkins Cancer Center - Baton Rouge	Baton Rouge	Louisiana
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	St. Joseph Medical Center	Bloomington	Illinois
United States	Fairview Ridges Hospital	Burnsville	Minnesota
United States	Graham Hospital	Canton	Illinois
United States	Memorial Hospital	Carthage	Illinois
United States	Cancer Center of Kansas - Chanute	Chanute	Kansas
United States	University of Illinois Medical Center	Chicago	Illinois
United States	Veterans Affairs Medical Center - Chicago Westside Hospital	Chicago	Illinois
United States	Adena Regional Medical Center	Chillicothe	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	North Idaho Cancer Center	Coeur d'Alene	Idaho
United States	CCOP - Columbus	Columbus	Ohio
United States	Doctors Hospital at Ohio Health	Columbus	Ohio
United States	Mount Carmel West Hospital	Columbus	Ohio
United States	Riverside Methodist Hospital Cancer Care	Columbus	Ohio
United States	Mercy Hospital	Coon Rapids	Minnesota
United States	Grady Memorial Hospital	Delaware	Ohio
United States	Denver Health Medical Center	Denver	Colorado
United States	St. Anthony Central Hospital	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	City of Hope Comprehensive Cancer Center	Duarte	California
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Cancer Center of Kansas, P.A. - El Dorado	El Dorado	Kansas
United States	Eureka Hospital	Eureka	Illinois
United States	Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital	Fairbanks	Alaska
United States	St. Francis Hospital	Federal Way	Washington
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	Mercy and Unity Cancer Center at Mercy and Unity Hospitals	Fridley	Minnesota
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	Great Falls Clinic	Great Falls	Montana
United States	CCOP - Greenville	Greenville	South Carolina
United States	Mason District Hospital	Havana	Illinois
United States	Hopedale Medical Complex	Hopedale	Illinois
United States	Community Oncology Group - Independence	Independence	Ohio
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Joliet Oncology Hematology Associates, Limited - West	Joliet	Illinois
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Veterans Affairs Medical Center - Kansas City	Kansas City	Missouri
United States	Kewanee Hospital	Kewanee	Illinois
United States	Cancer Center of Kansas - Kingman	Kingman	Kansas
United States	Cascade Cancer Center at Evergreen Hospital Medical Center	Kirkland	Washington
United States	Wilford Hall Medical Center	Lackland Air Force Base	Texas
United States	St. Clare Hospital	Lakewood	Washington
United States	Fairfield Medical Center	Lancaster	Ohio
United States	Southwest Medical Center	Liberal	Kansas
United States	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Logan Regional Hospital	Logan	Utah
United States	McDonough District Hospital	Macomb	Illinois
United States	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio
United States	Saint Anthony Memorial Health Centers	Michigan City	Indiana
United States	Virginia Piper Cancer Institute at Abbott-Northwestern Hospital	Minneapolis	Minnesota
United States	Montrose Memorial Hospital Cancer Center	Montrose	Colorado
United States	Cottonwood Hospital Medical Center	Murray	Utah
United States	Edward Hospital Cancer Center	Naperville	Illinois
United States	Cancer Center at Medical Center of Louisiana - New Orleans	New Orleans	Louisiana
United States	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio
United States	Cancer Center of Kansas - Newton	Newton	Kansas
United States	BroMenn Regional Medical Center	Normal	Illinois
United States	Community Cancer Center	Normal	Illinois
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	McKay-Dee Hospital Center	Ogden	Utah
United States	Capital Medical Center	Olympia	Washington
United States	Providence St. Peter Hospital Regional Cancer Center	Olympia	Washington
United States	M.D. Anderson Cancer Center - Orlando	Orlando	Florida
United States	Cancer Center of Kansas - Ottawa	Ottawa	Kansas
United States	Community Hospital of Ottawa	Ottawa	Illinois
United States	Oncology Hematology Associates of Central Illinois - Ottawa	Ottawa	Illinois
United States	Camden-Clark Memorial Hospital	Parkersburg	West Virginia
United States	Cancer Center of Kansas, P.A. - Parsons	Parsons	Kansas
United States	Cancer Treatment Center at Pekin Hospital	Pekin	Illinois
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	Oncology/Hematology Associates of Central Illinois, P.C.	Peoria	Illinois
United States	OSF St. Francis Medical Center	Peoria	Illinois
United States	Proctor Hospital	Peoria	Illinois
United States	Illinois Valley Community Hospital	Peru	Illinois
United States	CCOP - Western Regional, Arizona	Phoenix	Arizona
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	Olympic Medical Center	Port Angeles	Washington
United States	Pratt Cancer Center of Kansas	Pratt	Kansas
United States	Perry Memorial Hospital	Princeton	Illinois
United States	Utah Valley Regional Medical Center - Provo	Provo	Utah
United States	Good Samaritan Cancer Center	Puyallup	Washington
United States	Valley Medical Center	Renton	Washington
United States	Hubert H. Humphrey Cancer Center at North Memorial Medical Center	Robbinsdale	Minnesota
United States	University of California Davis Cancer Center	Sacramento	California
United States	Dixie Regional Medical Center	Saint George	Utah
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	United Hospital	Saint Paul	Minnesota
United States	Cancer Center of Kansas - Salina	Salina	Kansas
United States	Salina Regional Health Center	Salina	Kansas
United States	Huntsman Cancer Institute at University of Utah	Salt Lake City	Utah
United States	LDS Hospital	Salt Lake City	Utah
United States	CCOP - Virginia Mason Research Center	Seattle	Washington
United States	Mercy Medical Center - Sioux City	Sioux City	Iowa
United States	Siouxland Hematology-Oncology Associates	Sioux City	Iowa
United States	St. Luke's Regional Medical Center	Sioux City	Iowa
United States	Avera McKennan Hospital and University Health Center	Sioux Falls	South Dakota
United States	Medical X-Ray Center	Sioux Falls	South Dakota
United States	Sioux Valley Hospital and University of South Dakota Medical Center	Sioux Falls	South Dakota
United States	St. Margaret's Hospital	Spring Valley	Illinois
United States	Valley Cancer Center	Spring Valley	Illinois
United States	Community Hospital of Springfield and Clark County	Springfield	Ohio
United States	Mercy Medical Center Oncology Unit	Springfield	Ohio
United States	Park Nicollet Clinic	St. Louis Park	Minnesota
United States	Allenmore Hospital	Tacoma	Washington
United States	CCOP - Northwest	Tacoma	Washington
United States	St. Joseph Medical Center at Franciscan Health System	Tacoma	Washington
United States	Center for Cancer Prevention and Care at Scott and White Clinic	Temple	Texas
United States	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois
United States	Carle Clinic Association	Urbana	Illinois
United States	Ridgeview Medical Center	Waconia	Minnesota
United States	Cancer Center of Kansas - Wellington	Wellington	Kansas
United States	St. Anthony North Hospital	Westminster	Colorado
United States	Exempla Lutheran Medical Center	Wheat Ridge	Colorado
United States	Associates in Womens Health	Wichita	Kansas
United States	Cancer Center of Kansas, P.A. - Wichita	Wichita	Kansas
United States	CCOP - Wichita	Wichita	Kansas
United States	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas
United States	Cancer Center of Kansas - Winfield	Winfield	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
Southwest Oncology Group	Eastern Cooperative Oncology Group, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug	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	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	Yes