<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01673009</url>
  </required_header>
  <id_info>
    <org_study_id>0512-25</org_study_id>
    <nct_id>NCT01673009</nct_id>
  </id_info>
  <brief_title>Phase II Study of Gleevec/Imatinib Mesylate (STI-571, NCS 716051) in Neurofibromatosis (NF1) Patients With Plexiform Neurofibromas</brief_title>
  <official_title>Phase II Study of Gleevec/Imatinib Mesylate (STI-571, NCS 716051) in Neurofibromatosis (NF1) Patients With Plexiform Neurofibromas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      THe primary objective is to estimate the response rate at 6 months to Gleevec® in patients&#xD;
      with plexiform neurofibromas&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label Phase II Study to determine the efficacy of Gleevec® in&#xD;
      neurofibromatosis (NF1) patients with plexiform neurofibromas with the secondary goals of&#xD;
      determining the toxicity, and tumor markers in this genetically defined population. The&#xD;
      rationale for this study arises from the response of human and murine NF1 cells to Gleevec®&#xD;
      in vitro and the response of a single NF1 patient treated with Gleevec® for airway&#xD;
      compression by a plexiform neurofibroma with a dramatic response not previously seen in NF1&#xD;
      therapy. The plan of therapy will include oral dosing of Gleevec® at 440 mg/m^2/day (max 800&#xD;
      mg/day) for pediatric subjects and 800 mg/day for adult patients. (with 25% dose reduction&#xD;
      for significant toxicity). Treatment will continue for 6 months with an option to continue as&#xD;
      long as the patient remains on study provided the patient shows benefit from treatments with&#xD;
      Gleevec® and there are no safety concerns.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2006</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">December 2011</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Change From Baseline in Tumor Volume at 6 Months</measure>
    <time_frame>baseline to 6 months</time_frame>
    <description>Volumetric measures were performed using MRI scan analysis. Response criteria include greater than 20 percent decrease in tumor volume as responsive. Greater than 20 percent increase in tumor volume as tumor progression. Less then 20 percent increase or decrease in tumor volume is stable disease</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum Bioactivity</measure>
    <time_frame>7 days and 1 month</time_frame>
    <description>The investigators will quantitate the biologic activity of patient serum on fibroblast proliferation, migration, and collagen synthesis pre and post-Gleevec (7 days and 1 month)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Neurofibromatosis</condition>
  <arm_group>
    <arm_group_label>Administration of Gleevec</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gleevec® will be dosed orally 440 mg/m^2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gleevec</intervention_name>
    <description>Gleevec® will be dosed orally 440 mg/m^2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.</description>
    <arm_group_label>Administration of Gleevec</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients 3-65 years of age.&#xD;
&#xD;
          2. Diagnosis of neurofibromatosis (NF1), as outpatients.&#xD;
&#xD;
          3. Presence of clinically significant plexiform neurofibromas (biopsy proven if possible&#xD;
             with tissue blocks available); that is tumors that are potentially life threatening or&#xD;
             are impinging on vital structures or significantly impair the quality of life from&#xD;
             pain or other symptoms.&#xD;
&#xD;
          4. Patients must have measurable disease by magnetic resonance imaging (MRI). Patients&#xD;
             must have a Karnofsky or Lansky Performance score of &gt; 80% and a life expectancy of &gt;&#xD;
             2 months.&#xD;
&#xD;
          5. Adequate end organ function, defined as the following:&#xD;
&#xD;
             total bilirubin &lt; 1.5 x ULN, SGOT and SGPT &lt; 2.5 x UNL, creatinine &lt; 1.5 x ULN, ANC &gt;&#xD;
             1.5 x 109/L, platelets &gt; 100 x 109/L.&#xD;
&#xD;
          6. Female patients of childbearing potential must have negative pregnancy test within 7&#xD;
             days before initiation of study drug dosing. Postmenopausal women must be amenorrheic&#xD;
             for at least 12 months to be considered of non-childbearing potential. Male and female&#xD;
             patients of reproductive potential must agree to employ an effective barrier method of&#xD;
             birth control throughout the study and for up to 3 months following discontinuation of&#xD;
             study drug.&#xD;
&#xD;
          7. Written, voluntary informed consent.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Patient has received any other investigational agents within 28 days of first day of&#xD;
             study drug dosing, unless the disease is rapidly progressing.&#xD;
&#xD;
          2. Patient is &lt; 5 years free of another primary malignancy except: if the other primary&#xD;
             malignancy is not currently clinically significant nor requiring active intervention,&#xD;
             or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in&#xD;
             situ. Existence of any other malignant disease is not allowed.&#xD;
&#xD;
          3. Patient with Grade III/IV cardiac problems as defined by the New York Heart&#xD;
             Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6&#xD;
             months of study)&#xD;
&#xD;
          4. Female patients who are pregnant or breast-feeding.&#xD;
&#xD;
          5. Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes,&#xD;
             chronic renal disease, or active uncontrolled infection).&#xD;
&#xD;
          6. Patient has a known brain metastasis. Non-specific CNS changes on MRI/CT&#xD;
             characteristic of NF1 are allowed, but not known CNS malignancies.&#xD;
&#xD;
          7. Patient has known chronic liver disease (i.e., chronic active hepatitis, and&#xD;
             cirrhosis).&#xD;
&#xD;
          8. Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.&#xD;
&#xD;
          9. Patient received chemotherapy within 4 weeks (6 weeks for nitrosourea or mitomycin-C)&#xD;
             prior to study entry, unless the disease is rapidly progressing.&#xD;
&#xD;
         10. Patient previously received radiotherapy to greater than 25 % of the bone marrow&#xD;
&#xD;
         11. Patient had a major surgery within 2 weeks prior to study entry.&#xD;
&#xD;
         12. Patient with any significant history of non-compliance to medical regimens or with&#xD;
             inability to grant reliable informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Indiana University</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <results_first_submitted>February 24, 2016</results_first_submitted>
  <results_first_submitted_qc>April 5, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 6, 2016</results_first_posted>
  <last_update_submitted>April 5, 2016</last_update_submitted>
  <last_update_submitted_qc>April 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gleevec</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neurofibromatoses</mesh_term>
    <mesh_term>Neurofibromatosis 1</mesh_term>
    <mesh_term>Neurofibroma</mesh_term>
    <mesh_term>Neurofibroma, Plexiform</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Imatinib Mesylate</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Administration of Gleevec</title>
          <description>Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.&#xD;
Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Administration of Gleevec</title>
          <description>Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.&#xD;
Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="36"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Tumor Volume at 6 Months</title>
        <description>Volumetric measures were performed using MRI scan analysis. Response criteria include greater than 20 percent decrease in tumor volume as responsive. Greater than 20 percent increase in tumor volume as tumor progression. Less then 20 percent increase or decrease in tumor volume is stable disease</description>
        <time_frame>baseline to 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Administration of Gleevec</title>
            <description>Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.&#xD;
Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Tumor Volume at 6 Months</title>
          <description>Volumetric measures were performed using MRI scan analysis. Response criteria include greater than 20 percent decrease in tumor volume as responsive. Greater than 20 percent increase in tumor volume as tumor progression. Less then 20 percent increase or decrease in tumor volume is stable disease</description>
          <units>percentage change of tumor volume</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17" lower_limit="6" upper_limit="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Bioactivity</title>
        <description>The investigators will quantitate the biologic activity of patient serum on fibroblast proliferation, migration, and collagen synthesis pre and post-Gleevec (7 days and 1 month)</description>
        <time_frame>7 days and 1 month</time_frame>
        <population>unable to measure this outcome because assay became unavailable</population>
        <group_list>
          <group group_id="O1">
            <title>Administration of Gleevec</title>
            <description>Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.&#xD;
Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Bioactivity</title>
          <description>The investigators will quantitate the biologic activity of patient serum on fibroblast proliferation, migration, and collagen synthesis pre and post-Gleevec (7 days and 1 month)</description>
          <population>unable to measure this outcome because assay became unavailable</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Administration of Gleevec</title>
          <description>Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.&#xD;
Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (3.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>liver dysfunction/failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>CTCAE (3.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Edema</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Kent Robertson MD PhD</name_or_title>
      <organization>Indiana University</organization>
      <phone>317-944-8784</phone>
      <email>krobert@iu.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01673009
org study id: 0512-25
nct id: NCT01673009
lead sponsor: 
has dmc: Yes
THe primary objective is to estimate the response rate at 6 months to Gleevec® in patients
      with plexiform neurofibromas
This is an open-label Phase II Study to determine the efficacy of Gleevec® in
      neurofibromatosis (NF1) patients with plexiform neurofibromas with the secondary goals of
      determining the toxicity, and tumor markers in this genetically defined population. The
      rationale for this study arises from the response of human and murine NF1 cells to Gleevec®
      in vitro and the response of a single NF1 patient treated with Gleevec® for airway
      compression by a plexiform neurofibroma with a dramatic response not previously seen in NF1
      therapy. The plan of therapy will include oral dosing of Gleevec® at 440 mg/m^2/day (max 800
      mg/day) for pediatric subjects and 800 mg/day for adult patients. (with 25% dose reduction
      for significant toxicity). Treatment will continue for 6 months with an option to continue as
      long as the patient remains on study provided the patient shows benefit from treatments with
      Gleevec® and there are no safety concerns.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percent Change From Baseline in Tumor Volume at 6 Months
time frame: baseline to 6 months
description: Volumetric measures were performed using MRI scan analysis. Response criteria include greater than 20 percent decrease in tumor volume as responsive. Greater than 20 percent increase in tumor volume as tumor progression. Less then 20 percent increase or decrease in tumor volume is stable disease
measure: Serum Bioactivity
time frame: 7 days and 1 month
description: The investigators will quantitate the biologic activity of patient serum on fibroblast proliferation, migration, and collagen synthesis pre and post-Gleevec (7 days and 1 month)
arm group label: Administration of Gleevec
arm group type: Experimental
description: Gleevec® will be dosed orally 440 mg/m^2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.
intervention type: Drug
intervention name: Gleevec
description: Gleevec® will be dosed orally 440 mg/m^2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.
arm group label: Administration of Gleevec
criteria: 
gender: All
minimum age: 3 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neurofibromatoses
mesh term: Neurofibromatosis 1
mesh term: Neurofibroma
mesh term: Neurofibroma, Plexiform
mesh term: Imatinib Mesylate
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 