Clinical trial · Interventional
Hydroxyurea With or Without Imatinib Mesylate in Treating Patients With Recurrent or Progressive Meningioma
IMATINIB Plus Hydroxyurea in the Treatment of Recurrent or Progressive Meningiomas: a Randomized Phase II Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hydroxyurea | Drug | Hydroxyurea | ALIAS |
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral hydroxyurea twice daily and oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: hydroxyurea
- Drug: imatinib mesylate
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive oral hydroxyurea twice daily in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: hydroxyurea
Primary outcomes (1)
- measure
- Progression-free survival, defined as ≥ 25% increase in tumor volume or new tumor on MRI
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available