Brain and Central Nervous System TumorsPhase 2NCT00904735
Hydroxyurea With or Without Imatinib Mesylate in Treating Patients With Recurrent or Progressive Meningioma
A Phase 2 study testing hydroxyurea and imatinib mesylate in people with Brain and Central Nervous System Tumors, run by Istituto Scientifico H. San Raffaele at 5 sites in Italy.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as hydroxyurea, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- hydroxyurea and imatinib mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 5 sitesItaly
- Study dates
- Jun 2009to not given
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosed with meningioma
- WHO grade I-III
- Recurrent or progressive disease after prior surgery and radiotherapy, or radiosurgery
- Not amenable to further surgery
- No optic nerve sheet tumor and neurofibromatosis type II
- No known brain metastasis
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- ANC > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Hemoglobin ≥ 9 mg/dL (transfusion allowed)
- Total bilirubin < 1.5 times upper limit of normal (ULN)
- SGOT and SGPT < 2.5 times ULN
- Creatinine < 1.5 times ULN
- Negative pregnancy test
- Fertile patients must use effective barrier method contraception during and for up to 3 months after completion of study therapy
- No second malignancy
- No known chronic liver disease (i.e., active hepatitis, cirrhosis)
- No known HIV infection
- No significant history of non-compliance to medical regimens or inability to grant reliable informed consent
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No concurrent enzyme-inducing anti-epileptic drugs
- No concurrent therapeutic anticoagulation with warfarin (e.g., Coumadin®)
- Low-molecular weight heparin (e.g., Lovenox) or heparin allowed
- Mini-dose Coumadin® (e.g., 1 mg QD) allowed for prophylaxis of central venous catheter thrombosis, at the discretion of the treating physician
- No concurrent acetaminophen (Efferalgan®, Tachipirina®) allowed during imatinib mesylate administration
- No other concurrent anticancer agents, including chemotherapy or biological agents
- No other concurrent investigational drugs
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites, 5 recruiting
- Recruiting
Ospedale Civile Avellino
Avellino
Contact Person, 39-0825-203-232
- Recruiting
Ospedale Bellaria
Bologna, I-40139
Alba A. Brandes, MD, 39-51-622-5102, aa.brandes@yahoo.it
- Recruiting
Azienda Ospedaliero Careggi
Florence, 50139
Contact Person, 39-055-427-7111
- Recruiting
Istituto Nazionale Neurologico Carlo Besta
Milan, 20133
Contact Person, 39-02-2394-2341
- Recruiting
Ospedale Civile di Rovigo
Rovigo, 45100
Contact Person, 39-0425-393-016
About this study
Official title: IMATINIB Plus Hydroxyurea in the Treatment of Recurrent or Progressive Meningiomas: a Randomized Phase II Study
RATIONALE: Drugs used in chemotherapy, such as hydroxyurea, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether hydroxyurea is more effective when given alone or together with imatinib mesylate in treating patients with meningioma.
PURPOSE: This randomized phase II trial is studying how well hydroxyurea works compared with giving hydroxyurea together with imatinib mesylate in treating patients with recurrent or progressive meningioma.
Read the detailed description
OBJECTIVES:
Primary
- Assess the progression-free survival of patients with recurrent or progressive meningiomas treated with hydroxyurea with vs without imatinib mesylate after surgery and radiotherapy.
Secondary
- Determine the overall survival, and response rate of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to WHO grade (I vs II-III). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral hydroxyurea twice daily and oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral hydroxyurea twice daily in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed for up to 1 year.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- hydroxyurea, imatinib mesylate
- Keywords
- adult grade I meningioma, adult grade II meningioma, adult anaplastic meningioma, adult papillary meningioma, recurrent adult brain tumor
- Medical subject headings
- Central Nervous System Neoplasms, Meningioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydroxyureaDrug
Given orally
imatinib mesylateDrug
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oral hydroxyurea twice daily and oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity. Receives: Drug: hydroxyurea; Drug: imatinib mesylate |
| Arm II | Experimental | Patients receive oral hydroxyurea twice daily in the absence of disease progression or unacceptable toxicity. Receives: Drug: hydroxyurea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival, defined as ≥ 25% increase in tumor volume or new tumor on MRI
Secondary outcomes (3)
Survival
Response rate according to MacDonald criteria
Toxicity as assessed by NCI CTCAE v. 3.0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startJun 2009
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.
- 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
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Scientifico H. San Raffaele
- Sponsor type
- University, hospital or other
- Investigators
- Alba A. Brandes, MD, Study chair, Ospedale Bellaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904735
- Sponsor's protocol ID
- SRSI-GICNO-08-002
- Other IDs
- CDR0000641101, NOVARTIS-SRSI-GICNO-08-002
- Status last verified
- Jul 2009
- First submitted
- 19 May 2009
- Last updated
- 12 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMATINIB Plus Hydroxyurea in the Treatment of Recurrent or Progressive Meningiomas: a Randomized Phase II Study
- ClinicalTrials.gov ID
- NCT00904735
- Acronym / sponsor ID
- SRSI-GICNO-08-002
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- adult grade I meningioma, adult grade II meningioma, adult anaplastic meningioma, adult papillary meningioma, recurrent adult brain tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Istituto Scientifico H. San RaffaeleUniversity, hospital or other
- Study start
- Jun 2009
- First posted
- 20 May 2009 (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, such as hydroxyurea, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether hydroxyurea is more effective when given alone or together with imatinib mesylate in treating patients with meningioma.
PURPOSE: This randomized phase II trial is studying how well hydroxyurea works compared with giving hydroxyurea together with imatinib mesylate in treating patients with recurrent or progressive meningioma.
Detailed description
OBJECTIVES:
Primary
- Assess the progression-free survival of patients with recurrent or progressive meningiomas treated with hydroxyurea with vs without imatinib mesylate after surgery and radiotherapy.
Secondary
- Determine the overall survival, and response rate of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to WHO grade (I vs II-III). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral hydroxyurea twice daily and oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral hydroxyurea twice daily in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed for up to 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: hydroxyurea, Drug: imatinib mesylatePatients receive oral hydroxyurea twice daily and oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity. |
| Arm II | Experimental | Drug: hydroxyureaPatients receive oral hydroxyurea twice daily in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| hydroxyureaGiven orally | Drug | Arm I, Arm II |
| imatinib mesylateGiven orally | Drug | Arm I |
Primary outcome
Progression-free survival, defined as ≥ 25% increase in tumor volume or new tumor on MRI
3 secondary outcomes
Survival
Response rate according to MacDonald criteria
Toxicity as assessed by NCI CTCAE v. 3.0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
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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.
Alba A. Brandes, MD study chair
Ospedale Bellaria
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 and imatinib mesylate in people with Brain and Central Nervous System Tumors, run by Istituto Scientifico H. San Raffaele at 5 sites in Italy.
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: status not confirmed, as of the sponsor's last update on 12 Aug 2013. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival, defined as ≥ 25% increase in tumor volume or new tumor on MRI. It is what the study was designed to measure, not a finding.
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 12 Aug 2013; AzTrials last refreshed its copy on 6 Nov 2026.