S9811 Hydroxyurea in Treating Patients With Unresectable Benign Meningioma

April 20, 2016 updated by: Southwest Oncology Group

Phase II Study of Hydroxyurea for Unresectable Meningioma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alaska
      • Fairbanks, Alaska, United States, 99701
        • Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
    • Arizona
      • Phoenix, Arizona, United States, 85006-2726
        • CCOP - Western Regional, Arizona
      • Phoenix, Arizona, United States, 85001-2071
        • St. Joseph's Hospital and Medical Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope Comprehensive Cancer Center
      • Oakland, California, United States, 94609-3305
        • CCOP - Bay Area Tumor Institute
      • Sacramento, California, United States, 95817
        • University of California Davis Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80010
        • University of Colorado Cancer Center at University of Colorado Health Sciences Center
      • Denver, Colorado, United States, 80220
        • Veterans Affairs Medical Center - Denver
      • Denver, Colorado, United States, 80204-4507
        • Denver Health Medical Center
      • Denver, Colorado, United States, 80204-1335
        • St. Anthony Central Hospital
      • Montrose, Colorado, United States, 81401
        • Montrose Memorial Hospital Cancer Center
      • Westminster, Colorado, United States, 80030
        • St. Anthony North Hospital
      • Wheat Ridge, Colorado, United States, 80033
        • Exempla Lutheran Medical Center
    • Florida
      • Orlando, Florida, United States, 32806-2134
        • M.D. Anderson Cancer Center - Orlando
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • North Idaho Cancer Center
    • Illinois
      • Aurora, Illinois, United States, 60504-4206
        • Rush-Copley Cancer Care Center
      • Bloomington, Illinois, United States, 61701
        • St. Joseph Medical Center
      • Canton, Illinois, United States, 61520
        • Graham Hospital
      • Carthage, Illinois, United States, 62321
        • Memorial Hospital
      • Chicago, Illinois, United States, 60612
        • Veterans Affairs Medical Center - Chicago Westside Hospital
      • Chicago, Illinois, United States, 60612
        • University of Illinois Medical Center
      • Eureka, Illinois, United States, 61530
        • Eureka Hospital
      • Galesburg, Illinois, United States, 61401
        • Galesburg Cottage Hospital
      • Galesburg, Illinois, United States, 61401
        • Galesburg Clinic
      • Galesburg, Illinois, United States, 61401
        • InterCommunity Cancer Center of Western Illinois
      • Havana, Illinois, United States, 62644
        • Mason District Hospital
      • Hopedale, Illinois, United States, 61747
        • Hopedale Medical Complex
      • Joliet, Illinois, United States, 60435
        • Joliet Oncology Hematology Associates, Limited - West
      • Kewanee, Illinois, United States, 61443
        • Kewanee Hospital
      • Macomb, Illinois, United States, 61455
        • Mcdonough District Hospital
      • Naperville, Illinois, United States, 60540
        • Edward Hospital Cancer Center
      • Normal, Illinois, United States, 61761
        • Bromenn Regional Medical Center
      • Normal, Illinois, United States, 61761
        • Community Cancer Center
      • Ottawa, Illinois, United States, 61350
        • Community Hospital of Ottawa
      • Ottawa, Illinois, United States, 61350
        • Oncology Hematology Associates of Central Illinois - Ottawa
      • Pekin, Illinois, United States, 61554
        • Cancer Treatment Center at Pekin Hospital
      • Peoria, Illinois, United States, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, United States, 61614
        • Proctor Hospital
      • Peoria, Illinois, United States, 61637
        • OSF St. Francis Medical Center
      • Peoria, Illinois, United States, 61615-7828
        • CCOP - Illinois Oncology Research Association
      • Peoria, Illinois, United States, 61615-7828
        • Oncology/Hematology Associates of Central Illinois, P.C.
      • Peru, Illinois, United States, 61354
        • Illinois Valley Community Hospital
      • Princeton, Illinois, United States, 61356
        • Perry Memorial Hospital
      • Spring Valley, Illinois, United States, 61362
        • St. Margaret's Hospital
      • Spring Valley, Illinois, United States, 61362
        • Valley Cancer Center
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center at Carle Foundation Hospital
      • Urbana, Illinois, United States, 61801
        • Carle Clinic Association
    • Indiana
      • Michigan City, Indiana, United States, 46360-4358
        • Saint Anthony Memorial Health Centers
    • Iowa
      • Sioux City, Iowa, United States, 51104
        • St. Luke's Regional Medical Center
      • Sioux City, Iowa, United States, 51101-1733
        • Siouxland Hematology-Oncology Associates
      • Sioux City, Iowa, United States, 51101
        • Mercy Medical Center - Sioux City
    • Kansas
      • Chanute, Kansas, United States, 66720
        • Cancer Center of Kansas - Chanute
      • El Dorado, Kansas, United States, 67042
        • Cancer Center of Kansas, P.A. - El Dorado
      • Kingman, Kansas, United States, 67068
        • Cancer Center of Kansas - Kingman
      • Liberal, Kansas, United States, 67901
        • Southwest Medical Center
      • Newton, Kansas, United States, 67114
        • Cancer Center of Kansas - Newton
      • Ottawa, Kansas, United States, 66067
        • Cancer Center of Kansas - Ottawa
      • Parsons, Kansas, United States, 67357
        • Cancer Center of Kansas, P.A. - Parsons
      • Pratt, Kansas, United States, 67124
        • Pratt Cancer Center of Kansas
      • Salina, Kansas, United States, 67401
        • Salina Regional Health Center
      • Salina, Kansas, United States, 67401
        • Cancer Center of Kansas - Salina
      • Wellington, Kansas, United States, 67152
        • Cancer Center of Kansas - Wellington
      • Wichita, Kansas, United States, 67214-3882
        • CCOP - Wichita
      • Wichita, Kansas, United States, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Wichita, Kansas, United States, 67203
        • Associates In Womens Health
      • Wichita, Kansas, United States, 67214-3728
        • Cancer Center of Kansas, P.A. - Wichita
      • Winfield, Kansas, United States, 67156
        • Cancer Center of Kansas - Winfield
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Mary Bird Perkins Cancer Center - Baton Rouge
      • Baton Rouge, Louisiana, United States, 70821
        • Baton Rouge General Regional Cancer Center
      • New Orleans, Louisiana, United States, 70140-1015
        • Cancer Center at Medical Center of Louisiana - New Orleans
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • DeCesaris Cancer Institute at Anne Arundel Medical Center
      • Baltimore, Maryland, United States, 21231
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Josephine Ford Cancer Center at Henry Ford Health System
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, United States, 55432-2799
        • Mercy and Unity Cancer Center at Mercy and Unity Hospitals
      • Minneapolis, Minnesota, United States, 55407
        • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
      • Robbinsdale, Minnesota, United States, 55422-2900
        • Hubert H. Humphrey Cancer Center at North Memorial Medical Center
      • Saint Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
      • St. Louis Park, Minnesota, United States, 55416
        • Park Nicollet Clinic
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
    • Mississippi
      • Jackson, Mississippi, United States, 39216-4505
        • University of Mississippi Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Veterans Affairs Medical Center - Kansas City
      • Kansas City, Missouri, United States, 64131
        • CCOP - Kansas City
    • Montana
      • Billings, Montana, United States, 59101
        • CCOP - Montana Cancer Consortium
      • Great Falls, Montana, United States, 59403
        • Great Falls Clinic
    • Ohio
      • Chillicothe, Ohio, United States, 45601
        • Adena Regional Medical Center
      • Cleveland, Ohio, United States, 44195-9001
        • Cleveland Clinic Taussig Cancer Center
      • Columbus, Ohio, United States, 43214-3998
        • Riverside Methodist Hospital Cancer Care
      • Columbus, Ohio, United States, 43206
        • CCOP - Columbus
      • Columbus, Ohio, United States, 43228
        • Doctors Hospital at Ohio Health
      • Columbus, Ohio, United States, 43222
        • Mount Carmel West Hospital
      • Delaware, Ohio, United States, 43015
        • Grady Memorial Hospital
      • Independence, Ohio, United States, 44131
        • Community Oncology Group - Independence
      • Lancaster, Ohio, United States, 43130
        • Fairfield Medical Center
      • Marietta, Ohio, United States, 45750-1635
        • Strecker Cancer Center at Marietta Memorial Hospital
      • Newark, Ohio, United States, 43055-2899
        • Licking Memorial Cancer Care Program at Licking Memorial Hospital
      • Springfield, Ohio, United States, 45505
        • Community Hospital of Springfield and Clark County
      • Springfield, Ohio, United States, 45501
        • Mercy Medical Center Oncology Unit
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Rose Ramer Cancer Clinic at Anderson Area Medical Center
      • Greenville, South Carolina, United States, 29615
        • CCOP - Greenville
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Medical X-Ray Center
      • Sioux Falls, South Dakota, United States, 57104
        • Sioux Valley Hospital and University of South Dakota Medical Center
      • Sioux Falls, South Dakota, United States, 57105-1080
        • Avera McKennan Hospital and University Health Center
    • Texas
      • Fort Sam Houston, Texas, United States, 78234-6200
        • Brooke Army Medical Center
      • Lackland Air Force Base, Texas, United States, 78236-5300
        • Wilford Hall Medical Center
      • Temple, Texas, United States, 76508
        • Center for Cancer Prevention and Care at Scott and White Clinic
    • Utah
      • American Fork, Utah, United States, 84003
        • American Fork Hospital
      • Logan, Utah, United States, 84341
        • Logan Regional Hospital
      • Murray, Utah, United States, 84107
        • Cottonwood Hospital Medical Center
      • Ogden, Utah, United States, 84403
        • McKay-Dee Hospital Center
      • Provo, Utah, United States, 84604
        • Utah Valley Regional Medical Center - Provo
      • Saint George, Utah, United States, 84770
        • Dixie Regional Medical Center
      • Salt Lake City, Utah, United States, 84143
        • LDS Hospital
      • Salt Lake City, Utah, United States, 84112-5550
        • Huntsman Cancer Institute at University of Utah
    • Washington
      • Aberdeen, Washington, United States, 98520
        • Grays Harbor Community Hospital
      • Auburn, Washington, United States, 98001-4908
        • Auburn Regional Center for Cancer Care at Auburn Regional Medical Center
      • Federal Way, Washington, United States, 98003
        • St. Francis Hospital
      • Kirkland, Washington, United States, 98034-3013
        • Cascade Cancer Center at Evergreen Hospital Medical Center
      • Lakewood, Washington, United States, 98499-0998
        • St. Clare Hospital
      • Olympia, Washington, United States, 98502
        • Capital Medical Center
      • Olympia, Washington, United States, 98506
        • Providence St. Peter Hospital Regional Cancer Center
      • Port Angeles, Washington, United States, 98362
        • Olympic Medical Center
      • Puyallup, Washington, United States, 98371
        • Good Samaritan Cancer Center
      • Renton, Washington, United States, 98055
        • Valley Medical Center
      • Seattle, Washington, United States, 98101
        • CCOP - Virginia Mason Research Center
      • Tacoma, Washington, United States, 98405-0986
        • CCOP - Northwest
      • Tacoma, Washington, United States, 98405-3004
        • St. Joseph Medical Center at Franciscan Health System
      • Tacoma, Washington, United States, 98411-0414
        • Allenmore Hospital
    • West Virginia
      • Parkersburg, West Virginia, United States, 26102
        • Camden-Clark Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydroxyurea
Drug: hydroxyurea
20 mg/kg/day PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)
Time Frame: 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).
Patients treated for 2 years or progression. If responding can continue at physician's discretion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)
Eastern Cooperative Oncology Group

Investigators

  • Study Chair: Geoffrey R. Barger, MD, Barbara Ann Karmanos Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1998

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

May 20, 2016

Last Update Submitted That Met QC Criteria

April 20, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066659
  • U10CA032102 (U.S. NIH Grant/Contract)
  • S9811 (Other Identifier: SWOG)
  • ECOG-S9811 (Other Identifier: ECOG)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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