Brain and Central Nervous System TumorsPhase 2NCT00006119
Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma
A Phase 2 study testing hydroxyurea in people with Brain and Central Nervous System Tumors, run by UNICANCER at 5 sites in France.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of hydroxyurea in treating patients who have recurrent and/or unresectable meningioma. Read more about this study
- Who is it for?
- Ages 16 to 120 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- hydroxyurea
- How many people
- Not given
- Where
- 5 sitesFrance
- Study dates
- Jul 1999to Jan 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically proven progressive meningioma that is not curable by surgery
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Performance status:
- Karnofsky 70-100%
Life expectancy:
- Over 3 months
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- AST and ALT no greater than 2 times ULN
- Alkaline phosphatase no greater than 2 times ULN
Renal:
- Creatinine no greater than 2 times ULN
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 6 months after study
- No other malignancy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
- No other concurrent chemotherapy
Endocrine therapy:
- Concurrent corticosteroids allowed for control of intracranial pressure
Radiotherapy:
- Prior radiotherapy allowed
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
Other:
- At least 1 year since prior experimental therapy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Hopital Saint Andre
Bordeaux, 33075
Centre Leon Berard
Lyon, 69373
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, 34298
Centre Eugene Marquis
Rennes, 35042
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, 37044
About this study
Official title: Phase II Study of Hydroxyurea for the Treatment of Recurrent and/or Nonoperable Meningioma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of hydroxyurea in treating patients who have recurrent and/or unresectable meningioma.
Read the detailed description
OBJECTIVES:
- Determine complete, partial, or stable response to hydroxyurea in patients with recurrent and/or nonresectable meningioma.
- Determine response at 2 years to this regimen in these patients.
- Determine overall and disease free survival of these patients after this regimen.
- Determine quality of life of these patients.
- Determine the toxicities of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to grade of disease (I vs II or III).
Patients receive oral hydroxyurea daily for 2 years.
Quality of life is assessed before treatment, then every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- hydroxyurea
- Keywords
- recurrent adult brain tumor, adult grade III meningioma, adult grade I meningioma, adult grade II meningioma
- Medical subject headings
- Central Nervous System Neoplasms, Brain Neoplasms, Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydroxyureaDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJul 1999
- Primary completionDec 2004
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier Frappaz, MD, Study chair, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006119
- Sponsor's protocol ID
- CDR0000068132
- Other IDs
- FRE-FNCLCC-98009, EU-20018
- Status last verified
- Feb 2021
- First submitted
- 3 Aug 2000
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Hydroxyurea for the Treatment of Recurrent and/or Nonoperable Meningioma
- ClinicalTrials.gov ID
- NCT00006119
- Acronym / sponsor ID
- CDR0000068132
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- recurrent adult brain tumor, adult grade III meningioma, adult grade I meningioma, adult grade II meningioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- Jul 1999 (actual)
- Primary completion
- Dec 2004 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of hydroxyurea in treating patients who have recurrent and/or unresectable meningioma.
Detailed description
OBJECTIVES:
- Determine complete, partial, or stable response to hydroxyurea in patients with recurrent and/or nonresectable meningioma.
- Determine response at 2 years to this regimen in these patients.
- Determine overall and disease free survival of these patients after this regimen.
- Determine quality of life of these patients.
- Determine the toxicities of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to grade of disease (I vs II or III).
Patients receive oral hydroxyurea daily for 2 years.
Quality of life is assessed before treatment, then every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 16 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydroxyurea | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier Frappaz, MD study chair
Centre Leon Berard
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hydroxyurea in people with Brain and Central Nervous System Tumors, run by UNICANCER at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.