S9811 Hydroxyurea in Treating Patients With Unresectable Benign Meningioma
This study has been completed.
Sponsor:
Southwest Oncology Group
Collaborators:
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00003590
First received: November 1, 1999
Last updated: March 29, 2012
Last verified: March 2012
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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 | Intervention | Phase |
|---|---|---|
|
Adult Meningioma |
Drug: hydroxyurea |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Hydroxyurea for Unresectable Meningioma |
Resource links provided by NLM:
Further study details as provided by Southwest Oncology Group:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]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:
- Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug [ Time Frame: 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 ] [ Designated as safety issue: Yes ]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
| Enrollment: | 29 |
| Study Start Date: | November 1998 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Hydroxyurea |
Drug: hydroxyurea
20 mg/kg/day PO
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003590
Show 133 Study Locations
Show 133 Study LocationsSponsors and Collaborators
Southwest Oncology Group
Eastern Cooperative Oncology Group
Investigators
| Study Chair: | Lode J. Swinnen, MD | Sidney Kimmel Comprehensive Cancer Center |
| Study Chair: | Geoffrey R. Barger, MD | Barbara Ann Karmanos Cancer Institute |
More Information
Additional Information:
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.
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00003590 History of Changes |
| Other Study ID Numbers: | CDR0000066659, S9811, ECOG-S9811, U10CA032102 |
| Study First Received: | November 1, 1999 |
| Results First Received: | November 7, 2011 |
| Last Updated: | March 29, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Southwest Oncology Group:
|
recurrent adult brain tumor adult grade I meningioma |
Additional relevant MeSH terms:
|
Meningioma Neoplasms, Nerve Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Vascular Tissue Meningeal Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Nervous System Diseases |
Hydroxyurea Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antisickling Agents Hematologic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013