Imatinib Mesylate and Hydroxyurea in Treating Patients With Recurrent or Progressive Meningioma



Status:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:August 2005

Use our guide to learn which trials are right for you!

A Phase II Study of Imatinib Mesylate Plus Hydroxyurea in the Treatment of Patients With Recurrent/Progressive Meningioma


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.


OBJECTIVES:

Primary

- Evaluate the activity of imatinib mesylate and hydroxyurea, as measured by 6-month
progression-free survival, in patients with recurrent or progressive meningioma.

Secondary

- Evaluate the time to progression, overall survival, and objective response rate among
patients treated with this regimen.

- Assess the safety and tolerability of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive oral imatinib mesylate once or twice daily and oral hydroxyurea twice daily
on days 1-28. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.

PROJECTED ACCRUAL: A total of 21 patients will be accrued for this study.

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*

- AST and ALT < 2.5 times upper limit of normal (ULN)

- Bilirubin < 1.5 times ULN

- Creatinine < 1.5 times ULN OR creatinine clearance > 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 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
We found this trial at
1
site
20 Duke Clinic Cir
Durham, North Carolina 27710
(888) 275-3853
Duke Cancer Institute Leading-edge cancer care and research have been a hallmark of Duke Medicine...
?
mi
from
Durham, NC
Click here to add this to my saved trials