Phase 2
N=29
S9811 Hydroxyurea in Treating Patients With Unresectable Benign Meningioma
Adult Meningioma
Bottom Line
View on ClinicalTrials.gov: NCT00003590 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Feb 2012
Primary outcome: Primary: Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR) — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- hydroxyurea (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SWOG Cancer Research Network
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR) |
0; 0; 0; 0; 28 | — |
| SECONDARY Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug |
1; 1; 1; 1; 2; 1 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00003590). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.