Phase 2
N=21
Imatinib Mesylate and Hydroxyurea in Treating Patients With Recurrent or Progressive Meningioma
Glioblastoma · Gliosarcoma
Bottom Line
View on ClinicalTrials.gov: NCT00354913 ↗Enrolled (actual)
21
Serious AEs
4.8%
Results posted
Jan 2013
Primary outcome: Primary: Progression-free Survival at 6 Months — 61.9 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- hydroxyurea (Drug); imatinib mesylate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival at 6 Months |
61.9 | — |
| SECONDARY Median Progression-free Survival (PFS) |
7 | — |
| SECONDARY Median Overall Survival (OS) |
66 | — |
| SECONDARY Objective Response Rate |
— | — |
Summary
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Giving imatinib mesylate together with hydroxyurea may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving imatinib mesylate together with hydroxyurea works in treating patients with recurrent or progressive meningioma.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed meningioma
- Recurrent or progressive disease after prior surgical resection
- Measurable disease by contrast-enhanced MRI
- Multifocal disease allowed
- No evidence of intratumor hemorrhage on pretreatment diagnostic imaging
- Stable postoperative grade 1 hemorrhage allowed
- No peripheral edema or central or systemic fluid collections ≥ grade 2 (e.g., pericardial effusion, pulmonary effusion, ascites)
PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Absolute neutrophil count > 1,500/mm³
- Hemoglobin > 9 g/dL
- Platelet count > 100,000/mm³
- Potassium normal*
- Calcium normal*
- Magnesium normal*
- Phosphorus normal*
- alanine aminotransferase (AST) and alanine aminotransferase (ALT) 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No excessive risk of bleeding, as defined by stroke within the past 6 months
- No active systemic bleeding (i.e., gastrointestinal bleeding or gross hematuria)
- No history of central nervous system (CNS) or intraocular bleeding or septic endocarditis
- No concurrent severe and/or uncontrolled medical disease, including any of the following:
- Uncontrolled diabetes
- Congestive cardiac failure
- Myocardial infarction within the past 6 months
- Poorly controlled hypertension
- History of labile hypertension
- History of poor compliance with antihypertensive regimen
- Chronic renal disease
- Active uncontrolled infection requiring intravenous antibiotics
- No acute or chronic liver disease (i.e., hepatitis, cirrhosis)
- No HIV positivity
- No impairment of gastrointestinal function or disease that may significantly alter the absorption of imatinib mesylate, including any of the following:
- Ulcerative disease
- Uncontrolled nausea
- Vomiting
- Diarrhea
- Malabsorption syndrome
- Bowel obstruction
- Inability to swallow tablets
- No other malignancy within the past 5 years except basal cell skin cancer or cervical carcinoma in situ NOTE: *Unless correctable with supplements
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior therapy
- More than 1 week since prior tumor biopsy
- More than 2 weeks since prior surgical resection
- Prior hydroxyurea allowed provided patient has not had progressive disease or toxicity > grade 3
- No prior imatinib mesylate or other platelet-derived growth factor-directed therapy
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)*
- Chemotherapeutic agents such as etoposide that are normally given at shorter intervals allowed even if < 4 weeks from last prior dose of chemotherapy
- At least 4 weeks since prior radiotherapy*
- At least 1 week since prior biological, immunotherapeutic, or cytostatic drugs
- At least 2 weeks since prior investigational drugs
- No concurrent warfarin NOTE: *Unless there is unequivocal evidence of tumor progression
Data sourced from ClinicalTrials.gov (NCT00354913). 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.