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Imatinib Mesylate and Hydroxyurea in Treating Patients With Recurrent or Progressive Meningioma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), August 2008
First Received: July 19, 2006   Last Updated: October 22, 2008   History of Changes
Sponsors and Collaborators: Duke University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00354913
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: hydroxyurea
Drug: imatinib mesylate
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Imatinib Mesylate Plus Hydroxyurea in the Treatment of Patients With Recurrent/Progressive Meningioma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival at 6 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Objective response rate [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]
  • Tolerability [ Designated as safety issue: Yes ]

Estimated Enrollment: 21
Study Start Date: August 2005
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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*
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00354913

Locations
United States, North Carolina
Duke Comprehensive Cancer Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Clinical Trials Office - Duke Comprehensive Cancer Center     888-275-3853        
Sponsors and Collaborators
Duke University
Investigators
Study Chair: David A. Reardon, MD Duke University
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000482393, DUMC-7082-05-4R0, NOVARTIS-DUMC-7082-05-4R0
Study First Received: July 19, 2006
Last Updated: October 22, 2008
ClinicalTrials.gov Identifier: NCT00354913     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adult grade I meningioma
adult grade II meningioma
adult grade III meningioma
adult papillary meningioma
adult anaplastic meningioma
recurrent adult brain tumor

Study placed in the following topic categories:
Imatinib
Brain Neoplasms
Meningeal Neoplasms
Hydroxyurea
Meningioma
Central Nervous System Neoplasms
Protein Kinase Inhibitors
Recurrence
Nervous System Neoplasms

Additional relevant MeSH terms:
Meningeal Neoplasms
Antisickling Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Hydroxyurea
Antineoplastic Agents
Hematologic Agents
Neoplasms, Nerve Tissue
Nervous System Diseases
Enzyme Inhibitors
Central Nervous System Neoplasms
Protein Kinase Inhibitors
Pharmacologic Actions
Imatinib
Neoplasms
Neoplasms by Site
Therapeutic Uses
Neoplasms, Vascular Tissue
Meningioma
Nucleic Acid Synthesis Inhibitors
Nervous System Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009