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Adult MeningiomaPhase 2NCT00003590

S9811 Hydroxyurea in Treating Patients With Unresectable Benign Meningioma

A Phase 2 study testing hydroxyurea in people with Adult Meningioma, run by SWOG Cancer Research Network at 133 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Adult Meningioma
What is being tested?
hydroxyurea
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
133 sitesUnited States
Study dates
Nov 1998to Jul 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

133 sites in 1 country.

133 sites in 1 country

United States133 sites

  • Grays Harbor Community Hospital

    Aberdeen, Washington, 98520

  • American Fork Hospital

    American Fork, Utah, 84003

  • Rose Ramer Cancer Clinic at Anderson Area Medical Center

    Anderson, South Carolina, 29621

  • DeCesaris Cancer Institute at Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Auburn Regional Center for Cancer Care at Auburn Regional Medical Center

    Auburn, Washington, 98001-4908

  • University of Colorado Cancer Center at University of Colorado Health Sciences Center

    Aurora, Colorado, 80010

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60504-4206

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231

  • Mary Bird Perkins Cancer Center - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Baton Rouge General Regional Cancer Center

    Baton Rouge, Louisiana, 70821

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Graham Hospital

    Canton, Illinois, 61520

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • University of Illinois Medical Center

    Chicago, Illinois, 60612

  • Veterans Affairs Medical Center - Chicago Westside Hospital

    Chicago, Illinois, 60612

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195-9001

  • North Idaho Cancer Center

    Coeur d'Alene, Idaho, 83814

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • Mount Carmel West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • St. Anthony Central Hospital

    Denver, Colorado, 80204-1335

  • Denver Health Medical Center

    Denver, Colorado, 80204-4507

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado, 80220

  • Josephine Ford Cancer Center at Henry Ford Health System

    Detroit, Michigan, 48202

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas, P.A. - El Dorado

    El Dorado, Kansas, 67042

  • Eureka Hospital

    Eureka, Illinois, 61530

  • Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • St. Francis Hospital

    Federal Way, Washington, 98003

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234-6200

  • Mercy and Unity Cancer Center at Mercy and Unity Hospitals

    Fridley, Minnesota, 55432-2799

  • Galesburg Clinic

    Galesburg, Illinois, 61401

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • InterCommunity Cancer Center of Western Illinois

    Galesburg, Illinois, 61401

  • Great Falls Clinic

    Great Falls, Montana, 59403

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Mason District Hospital

    Havana, Illinois, 62644

  • Hopedale Medical Complex

    Hopedale, Illinois, 61747

  • Community Oncology Group - Independence

    Independence, Ohio, 44131

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Joliet Oncology Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Veterans Affairs Medical Center - Kansas City

    Kansas City, Missouri, 64128

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Kewanee Hospital

    Kewanee, Illinois, 61443

  • Cancer Center of Kansas - Kingman

    Kingman, Kansas, 67068

  • Cascade Cancer Center at Evergreen Hospital Medical Center

    Kirkland, Washington, 98034-3013

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236-5300

  • St. Clare Hospital

    Lakewood, Washington, 98499-0998

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Logan Regional Hospital

    Logan, Utah, 84341

  • McDonough District Hospital

    Macomb, Illinois, 61455

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750-1635

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360-4358

  • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Montrose Memorial Hospital Cancer Center

    Montrose, Colorado, 81401

  • Cottonwood Hospital Medical Center

    Murray, Utah, 84107

  • Edward Hospital Cancer Center

    Naperville, Illinois, 60540

  • Cancer Center at Medical Center of Louisiana - New Orleans

    New Orleans, Louisiana, 70140-1015

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio, 43055-2899

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • BroMenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center

    Normal, Illinois, 61761

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609-3305

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Capital Medical Center

    Olympia, Washington, 98502

  • Providence St. Peter Hospital Regional Cancer Center

    Olympia, Washington, 98506

  • M.D. Anderson Cancer Center - Orlando

    Orlando, Florida, 32806-2134

  • Community Hospital of Ottawa

    Ottawa, Illinois, 61350

  • Oncology Hematology Associates of Central Illinois - Ottawa

    Ottawa, Illinois, 61350

  • Cancer Center of Kansas - Ottawa

    Ottawa, Kansas, 66067

  • Camden-Clark Memorial Hospital

    Parkersburg, West Virginia, 26102

  • Cancer Center of Kansas, P.A. - Parsons

    Parsons, Kansas, 67357

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois, 61554

  • Proctor Hospital

    Peoria, Illinois, 61614

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615-7828

  • Oncology/Hematology Associates of Central Illinois, P.C.

    Peoria, Illinois, 61615-7828

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois Valley Community Hospital

    Peru, Illinois, 61354

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85001-2071

  • CCOP - Western Regional, Arizona

    Phoenix, Arizona, 85006-2726

  • Olympic Medical Center

    Port Angeles, Washington, 98362

  • Pratt Cancer Center of Kansas

    Pratt, Kansas, 67124

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • Good Samaritan Cancer Center

    Puyallup, Washington, 98371

  • Valley Medical Center

    Renton, Washington, 98055

  • Hubert H. Humphrey Cancer Center at North Memorial Medical Center

    Robbinsdale, Minnesota, 55422-2900

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Clinic

    Saint Louis Park, Minnesota, 55416

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • Salina Regional Health Center

    Salina, Kansas, 67401

  • Huntsman Cancer Institute at University of Utah

    Salt Lake City, Utah, 84112-5550

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • CCOP - Virginia Mason Research Center

    Seattle, Washington, 98101

  • Siouxland Hematology-Oncology Associates

    Sioux City, Iowa, 51101-1733

  • Mercy Medical Center - Sioux City

    Sioux City, Iowa, 51101

  • St. Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Sioux Valley Hospital and University of South Dakota Medical Center

    Sioux Falls, South Dakota, 57104

  • Avera McKennan Hospital and University Health Center

    Sioux Falls, South Dakota, 57105-1080

  • Medical X-Ray Center

    Sioux Falls, South Dakota, 57105

  • St. Margaret's Hospital

    Spring Valley, Illinois, 61362

  • Valley Cancer Center

    Spring Valley, Illinois, 61362

  • Mercy Medical Center Oncology Unit

    Springfield, Ohio, 45501

  • Community Hospital of Springfield and Clark County

    Springfield, Ohio, 45505

  • Dixie Regional Medical Center

    St. George, Utah, 84770

  • CCOP - Northwest

    Tacoma, Washington, 98405-0986

  • St. Joseph Medical Center at Franciscan Health System

    Tacoma, Washington, 98405-3004

  • Allenmore Hospital

    Tacoma, Washington, 98411-0414

  • Center for Cancer Prevention and Care at Scott and White Clinic

    Temple, Texas, 76508

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois, 61801

  • Carle Clinic Association

    Urbana, Illinois, 61801

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • St. Anthony North Hospital

    Westminster, Colorado, 80030

  • Exempla Lutheran Medical Center

    Wheat Ridge, Colorado, 80033

  • Associates in Womens Health

    Wichita, Kansas, 67203

  • Cancer Center of Kansas, P.A. - Wichita

    Wichita, Kansas, 67214-3728

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
hydroxyurea
Keywords
recurrent adult brain tumor, adult grade I meningioma
Medical subject headings
Meningioma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hydroxyureaDrug

    20 mg/kg/day PO

Study groups in NCT00003590
Study groupRoleWhat they receive
HydroxyureaExperimentalNot described
Receives: Drug: hydroxyurea

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

Secondary outcomes (1)

  1. 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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startNov 1998
  3. Primary completionDec 2008
  4. Study completionJul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003590
Sponsor's protocol ID
CDR0000066659
Other IDs
S9811, ECOG-S9811, U10CA032102
Status last verified
Apr 2016
First submitted
1 Nov 1999
Last updated
20 May 2016
Data monitoring committee
No

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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing hydroxyurea in people with Adult Meningioma, run by SWOG Cancer Research Network at 133 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 133 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003590, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2016.

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