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Phase II Study of Hydroxyurea for Unresectable Meningioma

Phase 2
18 Years
Not Enrolling
Adult Meningioma

Thank you

Trial Information

Phase II Study of Hydroxyurea for Unresectable Meningioma


- 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

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.

Inclusion Criteria


- Histologically confirmed unresectable primary, recurrent, or residual benign

- 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



- 18 and over

Performance status:

- SWOG 0-2

Life expectancy:

- Not specified


- WBC at least 4,000/mm^3

- Platelet count at least lower limit of normal


- Not specified


- Not specified


- 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


Biologic therapy:

- Not specified


- 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


- See Disease Characteristics

- At least 6 months since prior radiotherapy

- No concurrent radiotherapy


- Not specified

Type of Study:


Study Design:

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

Outcome Measure:

Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)

Outcome Description:

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).

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Lode J. Swinnen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

November 1998

Completion Date:

July 2011

Related Keywords:

  • Adult Meningioma
  • recurrent adult brain tumor
  • adult grade I meningioma
  • Meningioma



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