S9811 Hydroxyurea in Treating Patients With Unresectable Benign Meningioma
- Registration Number
- NCT00003590
- Lead Sponsor
- SWOG Cancer Research Network
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hydroxyurea hydroxyurea -
- Primary Outcome Measures
Name Time Method Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR) 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).
- Secondary Outcome Measures
Name Time Method Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug 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
Related Research Topics
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Trial Locations
- Locations (133)
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
🇺🇸Fairbanks, Alaska, United States
St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
CCOP - Western Regional, Arizona
🇺🇸Phoenix, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
🇺🇸Aurora, Colorado, United States
St. Anthony Central Hospital
🇺🇸Denver, Colorado, United States
Denver Health Medical Center
🇺🇸Denver, Colorado, United States
Scroll for more (123 remaining)Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital🇺🇸Fairbanks, Alaska, United States