Hydroxyurea

Droxia; Hydrea

Clinical Trial: Hydroxyurea in Treating Patients With Unresectable Benign Meningioma

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Purpose
Eligibility
Location and Contact Information
More Information

This study is currently recruiting patients.

Sponsors and Collaborators:	Southwest Oncology Group National Cancer Institute (NCI) Eastern Cooperative Oncology Group
Information provided by:	National Cancer Institute (NCI)

Purpose

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.

Condition	Treatment or Intervention	Phase
recurrent adult brain tumor grade I meningioma	Drug: hydroxyurea Procedure: chemotherapy	Phase II

MedlinePlus related topics: Brain Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Hydroxyurea in Patients With Unresectable Benign Meningioma

Further Study Details:

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.

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

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

Location and Contact Information

Alaska
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital, Fairbanks, Alaska, 99701, United States; Recruiting

John M. Corman, MD 206-223-6177

Arizona
CCOP - Western Regional, Arizona, Phoenix, Arizona, 85006-2726, United States; Recruiting

David Kyle King, MD, FACP 602-258-4875 david.king@baannerhealth.com

St. Joseph's Hospital and Medical Center, Phoenix, Arizona, 85001-2071, United States; Recruiting

David Kyle King, MD, FACP 602-258-4875

Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States; Recruiting

Laura Fulper Hutchins, MD 501-686-8274 LFHutchins@uams.edu

California
CCOP - Bay Area Tumor Institute, Oakland, California, 94609-3305, United States; Recruiting

James H. Feusner, MD 510-428-3689 jfeusner@mail.cho.org

City of Hope Comprehensive Cancer Center, Duarte, California, 91010-3000, United States; Recruiting

Robert Joseph Morgan, MD 626-359-8111 rmorgan@coh.org

University of California Davis Cancer Center, Sacramento, California, 95817, United States; Recruiting

David R. Gandara, MD 916-734-3771 dgandara@cc.ucdmc.ucdavis.edu

Colorado
Denver Health Medical Center, Denver, Colorado, 80204-4507, United States; Recruiting

Anthony D. Elias, MD 303-436-6000

Exempla Lutheran Medical Center, Wheat Ridge, Colorado, 80033, United States; Recruiting

Anthony D. Elias, MD 303-425-4500 anthony.elias@uchs.edu

Montrose Memorial Hospital Cancer Center, Montrose, Colorado, 81401, United States; Recruiting

Anthony D. Elias, MD 970-249-2211 anthony.elias@uchsc.edu

St. Anthony Central Hospital, Denver, Colorado, 80204-1335, United States; Recruiting

Anthony D. Elias, MD 303-629-3511 anthony.elias@uchsc.edu

St. Anthony North Hospital, Westminster, Colorado, 80030, United States; Recruiting

Anthony D. Elias, MD 303-426-2151 anthony.elias@uchsc.edu

University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora, Colorado, 80010, United States; Recruiting

Anthony D. Elias, MD 720-848-1622 Anthony.Elias@uchsc.edu

Veterans Affairs Medical Center - Denver, Denver, Colorado, 80220, United States; Recruiting

Anthony D. Elias, MD 303-393-4698

Florida
M.D. Anderson Cancer Center - Orlando, Orlando, Florida, 32806-2134, United States; Recruiting

Omar Roger Kayaleh, MD 321-841-8403

Idaho
North Idaho Cancer Center, Coeur D Alene, Idaho, 83814, United States; Recruiting

John M. Corman, MD 206-223-6177

Illinois
BroMenn Regional Medical Center, Normal, Illinois, 61761, United States; Recruiting

John W. Kugler, MD 309-636-3606

Cancer Treatment Center at Pekin Hospital, Pekin, Illinois, 61554, United States; Recruiting