<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/NCT03275818</url>
  </required_header>
  <id_info>
    <org_study_id>GEIS-39</org_study_id>
    <secondary_id>2016-002464-14</secondary_id>
    <nct_id>NCT03275818</nct_id>
  </id_info>
  <brief_title>Trial of Nab-paclitaxel in Patients With Desmoid Tumors and Multiply Relapsed/Refractory Desmoplastic Small Round Cell Tumors and Ewing Sarcoma</brief_title>
  <acronym>ABRADES</acronym>
  <official_title>Phase II Trial of Nab-paclitaxel for the Treatment of Desmoid Tumors and Multiply Relapsed/Refractory Desmoplastic Small Round Cell Tumors and Ewing Sarcoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grupo Espanol de Investigacion en Sarcomas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Grupo Espanol de Investigacion en Sarcomas</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A two-cohort, fase II, open-label, non-randomized, multicenter clinical trial. 14 sites in&#xD;
      Spain.&#xD;
&#xD;
      Cohort 1: Subjects with desmoid tumor (DT) Cohort 2: Subjects with desmoplastic small round&#xD;
      cell tumor or Ewing sarcoma (DSRCT and ES)&#xD;
&#xD;
      Nab-paclitaxel (ABRAXANE) will be administered as follows:&#xD;
&#xD;
      Age ≥ 21 and ≤ 80 years: 125 mg/m2 days 1, 8 and 15 in cycles of 28 days Age ≥ 6 months and ≤&#xD;
      20 years: 240 mg/m2 days 1, 8 and 15 in cycles of 28 days&#xD;
&#xD;
      Subjects in the DT cohort will receive a maximum of three cycles. Subjects in the DSRCT and&#xD;
      ES cohort will receive unlimited cycles until disease progression, the subject begins a new&#xD;
      anticancer treatment, withdrawal of parent/guardian/subject consent/assent,&#xD;
      parent/guardian/subject refusal, physician decision, toxicity that cannot be managed by dose&#xD;
      delay or dose reduction alone or the study ends for any reason.&#xD;
&#xD;
      The main goal is to determine the objective response rate (ORR), using RECIST 1.1 criteria&#xD;
      and to determine the clinical benefit rate (CBR), defined as CR+PR+SD for 3 months with&#xD;
      improvement of pain with at least minimally important difference (MID) of 2 in subjects with&#xD;
      desmoid tumors (DT cohort) and to determine the objective response rate (ORR) in subjects&#xD;
      with desmoplastic small round cell tumor and Ewing sarcoma, using RECIST 1.1 criteria (DSRCT&#xD;
      and ES cohort)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 9, 2017</start_date>
  <completion_date type="Actual">September 30, 2021</completion_date>
  <primary_completion_date type="Actual">September 30, 2021</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>Overall response rate (ORR) - cohort 1</measure>
    <time_frame>3 months</time_frame>
    <description>TD cohort: Overall response rate (ORR) according to RECIST 1.1 and/or clinical benefit rate (CBR) at 3 months with pain improvement of at least 2 points in the Brief Pain Inventory - Short Form (BPI-SF)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Objective response rate (ORR) - cohort 2</measure>
    <time_frame>2 months</time_frame>
    <description>DSRCT and SE cohort: To determine the objective response rate (ORR) in subjects with desmoplastic small round cell tumor and Ewing's sarcoma, using RECIST 1.1 criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pattern of radiological response - cohort 1</measure>
    <time_frame>3 months</time_frame>
    <description>TD cohort: To define the pattern of radiological response according to MRI parameters and to correlate it with CBR and Brief Pain Inventory (BPI) parameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival - cohort 1</measure>
    <time_frame>3 months</time_frame>
    <description>TD cohort: To estimate the efficacy of nab-paclitaxel as measured by the progression-free survival (PFS) assessed by median time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation of symptoms - cohort 1</measure>
    <time_frame>during first year</time_frame>
    <description>TD cohort: To analyze the variation of symptoms during the first year from trial enrollment in accordance with BPI and Analgesic Quantification Algorithm (AQA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation of physical function - cohort 1</measure>
    <time_frame>during first year</time_frame>
    <description>TD cohort: To analyze the variation of physical function during the first year from trial enrollment in accordance with sponsor form.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety profile of nab-paclitaxel - cohort 1</measure>
    <time_frame>up to 12 months</time_frame>
    <description>TD cohort: To evaluate the safety profile of nab-paclitaxel according to CTCAE 4.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety profile of nab-paclitaxel - cohort 2</measure>
    <time_frame>up to 12 months</time_frame>
    <description>DSRCT and SE cohort: To evaluate the safety profile of nab-paclitaxel according to CTCAE 4.0.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Tumor, Desmoplastic Small Round Cell, Adult</condition>
  <condition>Tumor, Desmoplastic Small Round Cell, Childhood</condition>
  <condition>Sarcoma, Ewing</condition>
  <condition>Sarcoma</condition>
  <condition>Desmoid</condition>
  <arm_group>
    <arm_group_label>nab-paclitaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>nab-paclitaxel (ABRAXANE) will be administered as follows:&#xD;
Age ≥ 21: 125 mg/m2 days 1, 8 and 15 in cycles of 28 days&#xD;
Age ≥ 6 months and ≤ 20 years: 240 mg/m2 (for patients weighing &gt; 10 kg) and 11.5 mg/kg (for patients weighing ≤ 10 kg) on days 1, 8 and 15 in cycles of 28 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>nab paclitaxel</intervention_name>
    <description>Subjects in the DT cohort will receive a maximum of three cycles. Subjects in the DSRCT and ES cohort will receive unlimited cycles until disease progression, the subject begins a new anticancer treatment, withdrawal of parent/guardian/subject consent/assent, parent/guardian/subject refusal, physician decision, toxicity that cannot be managed by dose delay or dose reduction alone or the study ends for any reason</description>
    <arm_group_label>nab-paclitaxel</arm_group_label>
    <other_name>Abraxane</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        TD Cohort&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects (parent or legal guardian if subject under 18 years) must voluntarily sign&#xD;
             the informed consent form before any study test is conducted that is not part of&#xD;
             routine subject care.&#xD;
&#xD;
          2. Subjects with pathologic diagnosis of deep desmoid tumor of extremities, trunk wall or&#xD;
             head and neck region.Intra-abdominal desmoid tumor cases could be enrolled if&#xD;
             harboring betacatenin mutation.&#xD;
&#xD;
          3. Subjects must be symptomatic (pain) due to tumor desmoid mass or lack physical&#xD;
             function due to desmoid tumor mass, or in RECIST progression in the last 6 months.&#xD;
&#xD;
          4. Age: ≥ 6 months.&#xD;
&#xD;
          5. Subjects could have received one previous chemotherapy line if the scheme was&#xD;
             methotrexate plus vinca alkaloids. Patients who received prostaglandin inhibitors or&#xD;
             hormone therapy are also eligible.&#xD;
&#xD;
          6. Availability of archive tumor block.&#xD;
&#xD;
          7. Measurable disease, according to RECIST 1.1 criteria.&#xD;
&#xD;
          8. Performance status ≤1 (ECOG).&#xD;
&#xD;
          9. Normal ECG values.&#xD;
&#xD;
         10. Adequate bone marrow function (hemoglobin ≥ 9 g/dL, leukocytes ≥ 3.000/mm3,&#xD;
             neutrophils ≥ 1.500/mm3, platelets ≥ 100.000/mm3). Subjects with plasma creatinine ≤&#xD;
             1.6 mg/dl, transaminases ≤ 2.5 times the ULN, total bilirubin ≤ 1.25 times the ULN are&#xD;
             acceptable.&#xD;
&#xD;
         11. Men or women of childbearing potential must use an effective method of contraception&#xD;
             before entry into the study and throughout the same and for 6 months after ending the&#xD;
             study treatment. Women of childbearing potential must have a negative urine or serum&#xD;
             pregnancy test before study entry.&#xD;
&#xD;
         12. HBV and HCV serologies must be performed prior to inclusion. If HbsAg is positive it&#xD;
             is recommended to reject the existence of replicative phase (HbaAg+, DNA VHB+)&#xD;
             remaining at investigators' discretion the preventive treatment with lamivudine. If a&#xD;
             potential subject is positive for anti-HCV antibodies, presence of the virus should be&#xD;
             ruled out with a qualitative PCR, or the subject should NOT be included in the study&#xD;
             (if a qualitative PCR cannot be performed then subject will not be able to enter the&#xD;
             study).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior taxane therapy for any indication.&#xD;
&#xD;
          2. Less than 4 weeks elapsed since prior exposure to chemotherapy.&#xD;
&#xD;
          3. More than one previous chemotherapy line.&#xD;
&#xD;
          4. Subjects with desmoid tumor of abdominal cavity (abdominal wall is not an exclusion&#xD;
             criterion)&#xD;
&#xD;
          5. Desmoid tumor with ill-defined margins.&#xD;
&#xD;
          6. Unavailability to undergo MRI.&#xD;
&#xD;
          7. Previously irradiated target lesion (if radiation dose exceeded 50 Gy).&#xD;
&#xD;
          8. Pre-existing neuropathy greater than grade 1.&#xD;
&#xD;
          9. Other active invasive malignancy requiring ongoing therapy or expected to require&#xD;
             systemic therapy within two years. However, localized squamous cell carcinoma of the&#xD;
             skin, basal cell carcinoma of the skin, carcinoma in situ of the cervix or other&#xD;
             malignancies requiring only locally ablative therapy, will not result in exclusion.&#xD;
&#xD;
         10. Concomitant anticancer therapy, immunotherapy or radiation therapy within prior 4&#xD;
             weeks.&#xD;
&#xD;
         11. Uncontrolled intercurrent illness including but not limited to ongoing or active&#xD;
             infection requiring IV antibiotic, symptomatic congestive heart failure, unstable&#xD;
             angina pectoris, cardiac arrhythmia, psychiatric illness or social situations that&#xD;
             would limit compliance with study requirements&#xD;
&#xD;
         12. Hb &lt; 9 g/dL.&#xD;
&#xD;
         13. Women who are pregnant or breast-feeding.&#xD;
&#xD;
         14. Known hypersensitivity to protein bound paclitaxel&#xD;
&#xD;
         15. Any other concurrent condition that in the investigators opinion would jeopardize&#xD;
             compliance with the protocol&#xD;
&#xD;
         16. Known positive test for infection by human immunodeficiency virus (HIV).&#xD;
&#xD;
         17. Subjects participating in another clinical trial or receiving any other&#xD;
             investigational product.&#xD;
&#xD;
        DSRCT and ES Cohort&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects or legal guardian must voluntarily sign the informed consent form before any&#xD;
             study test is conducted that is not part of routine subject care.&#xD;
&#xD;
          2. Subject diagnosed of relapsed/refractory desmoplastic small round cell tumor (DSRCT)&#xD;
             or Ewing´s sarcoma.&#xD;
&#xD;
          3. DSRCT subjects must have received at least one previous poli-chemotherapy line.&#xD;
&#xD;
          4. Ewing´s sarcoma subjects must have received at least two standard chemotherapy lines.&#xD;
&#xD;
          5. Age ≥ 6 months&#xD;
&#xD;
          6. Availability of archive tumor blocks or slides (new biopsy recommended).&#xD;
&#xD;
          7. Measurable disease, according to RECIST 1.1 criteria.&#xD;
&#xD;
          8. Performance status ≤1 (ECOG).&#xD;
&#xD;
          9. Adequate respiratory functions: FEV1 &gt; 1L.&#xD;
&#xD;
         10. Normal ECG values.&#xD;
&#xD;
         11. Adequate bone marrow function (hemoglobin ≥ 9 g/dL, leukocytes ≥ 3,000/mm3,&#xD;
             neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3). Subjects with plasma creatinine ≤&#xD;
             1.6 mg/dL, transaminases ≤ 2.5 times the ULN, total bilirubin ≥ 1.25 times ULN, CPK ≤&#xD;
             2.5 times ULN, alkaline phosphatase ≤ 2.5 times the ULN are acceptable. If alkaline&#xD;
             phosphatase is &gt; 2.5 times the ULN, then the alkaline phosphatase liver fraction&#xD;
             and/or 5' nucleotidase and/or GGT must be ≤ ULN.&#xD;
&#xD;
         12. Men or women of child bearing potential should be using an effective method of&#xD;
             contraception before entry into the study and throughout the same and for 6 months&#xD;
             after ending the study. Women of childbearing potential must have a negative urine&#xD;
             pregnancy test before study entry.&#xD;
&#xD;
         13. HBV and HCV serologies must be performed prior to inclusion. If HbsAg is positive it&#xD;
             is recommended to reject the existence of replicative phase (HbaAg+, DNA VHB+)&#xD;
             remaining at investigators' discretion the preventive treatment with lamivudine. If a&#xD;
             potential subject is positive for anti-HCV antibodies, presence of the virus should be&#xD;
             ruled out with a qualitative PCR, or the subject should NOT be included in the study&#xD;
             (if a qualitative PCR cannot be performed then subject will not be able to enter the&#xD;
             study).&#xD;
&#xD;
         14. Prior taxane therapy for any indication is accepted.&#xD;
&#xD;
         15. &gt; Grade 3 (intense and diffuse) expression of SPARC by immunohistochemistry.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Less than 4 weeks elapsed since prior exposure to chemotherapy.&#xD;
&#xD;
          2. Pre-existing neuropathy greater than Grade 1.&#xD;
&#xD;
          3. Other active invasive malignancy requiring ongoing therapy or expected to require&#xD;
             systemic therapy within two years. However, localized squamous cell carcinoma of the&#xD;
             skin, basal cell carcinoma of the skin, carcinoma in situ of the cervix or other&#xD;
             malignancies requiring only locally ablative therapy, will not result in exclusion.&#xD;
&#xD;
          4. Concomitant anticancer therapy, immunotherapy or radiation therapy within prior 4&#xD;
             weeks.&#xD;
&#xD;
          5. Uncontrolled intercurrent illness including but not limited to ongoing or active&#xD;
             infection requiring IV antibiotic, symptomatic congestive heart failure, unstable&#xD;
             angina pectoris, cardiac arrhythmia, psychiatric illness or social situations that&#xD;
             would limit compliance with study requirements&#xD;
&#xD;
          6. Hb &lt; 9 g/dL.&#xD;
&#xD;
          7. Women who are pregnant or breast-feeding.&#xD;
&#xD;
          8. Known hypersensitivity to protein bound paclitaxel.&#xD;
&#xD;
          9. Any other concurrent condition that in the investigators opinion would jeopardize&#xD;
             compliance with the protocol.&#xD;
&#xD;
         10. Known positive test for infection by human immunodeficiency virus (HIV).&#xD;
&#xD;
         11. Subjects participating in another clinical trial or receiving any other&#xD;
             investigational product.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Javier Martin Broto, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hospitales Universitarios Virgen del Rocío</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jaume Mora, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Sant Joan de Deu</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Javier Martínez Trufero, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Miguel Servet</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Francisco Bautista, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario Niño Jesús</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Antonio López Pousa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Roberto Díaz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario La Fe</affiliation>
  </overall_official>
  <overall_official>
    <last_name>José Antonio López-Martín, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario 12 de Octubre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>H. de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. Sant Joan de Déu</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H.U. 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H.U.Niño Jesús</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H.U. Virgen del Rocío</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H.U i Politècnic La Fe</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H.U. Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>June 6, 2022</last_update_submitted>
  <last_update_submitted_qc>June 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sarcoma</keyword>
  <keyword>Desmoid tumor</keyword>
  <keyword>Desmoplastic small round cell tumor</keyword>
  <keyword>Ewing sarcoma</keyword>
  <keyword>relapsed</keyword>
  <keyword>refractory</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Sarcoma</mesh_term>
    <mesh_term>Sarcoma, Ewing</mesh_term>
    <mesh_term>Fibromatosis, Aggressive</mesh_term>
    <mesh_term>Desmoplastic Small Round Cell Tumor</mesh_term>
    <mesh_term>Neuroectodermal Tumors, Primitive, Peripheral</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03275818
org study id: GEIS-39
secondary id: 2016-002464-14
nct id: NCT03275818
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A two-cohort, fase II, open-label, non-randomized, multicenter clinical trial. 14 sites in
      Spain.

      Cohort 1: Subjects with desmoid tumor (DT) Cohort 2: Subjects with desmoplastic small round
      cell tumor or Ewing sarcoma (DSRCT and ES)

      Nab-paclitaxel (ABRAXANE) will be administered as follows:

      Age ≥ 21 and ≤ 80 years: 125 mg/m2 days 1, 8 and 15 in cycles of 28 days Age ≥ 6 months and ≤
      20 years: 240 mg/m2 days 1, 8 and 15 in cycles of 28 days

      Subjects in the DT cohort will receive a maximum of three cycles. Subjects in the DSRCT and
      ES cohort will receive unlimited cycles until disease progression, the subject begins a new
      anticancer treatment, withdrawal of parent/guardian/subject consent/assent,
      parent/guardian/subject refusal, physician decision, toxicity that cannot be managed by dose
      delay or dose reduction alone or the study ends for any reason.

      The main goal is to determine the objective response rate (ORR), using RECIST 1.1 criteria
      and to determine the clinical benefit rate (CBR), defined as CR+PR+SD for 3 months with
      improvement of pain with at least minimally important difference (MID) of 2 in subjects with
      desmoid tumors (DT cohort) and to determine the objective response rate (ORR) in subjects
      with desmoplastic small round cell tumor and Ewing sarcoma, using RECIST 1.1 criteria (DSRCT
      and ES cohort)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall response rate (ORR) - cohort 1
time frame: 3 months
description: TD cohort: Overall response rate (ORR) according to RECIST 1.1 and/or clinical benefit rate (CBR) at 3 months with pain improvement of at least 2 points in the Brief Pain Inventory - Short Form (BPI-SF)
measure: Objective response rate (ORR) - cohort 2
time frame: 2 months
description: DSRCT and SE cohort: To determine the objective response rate (ORR) in subjects with desmoplastic small round cell tumor and Ewing's sarcoma, using RECIST 1.1 criteria
measure: Pattern of radiological response - cohort 1
time frame: 3 months
description: TD cohort: To define the pattern of radiological response according to MRI parameters and to correlate it with CBR and Brief Pain Inventory (BPI) parameters.
measure: Progression-free survival - cohort 1
time frame: 3 months
description: TD cohort: To estimate the efficacy of nab-paclitaxel as measured by the progression-free survival (PFS) assessed by median time.
measure: Variation of symptoms - cohort 1
time frame: during first year
description: TD cohort: To analyze the variation of symptoms during the first year from trial enrollment in accordance with BPI and Analgesic Quantification Algorithm (AQA).
measure: Variation of physical function - cohort 1
time frame: during first year
description: TD cohort: To analyze the variation of physical function during the first year from trial enrollment in accordance with sponsor form.
measure: Safety profile of nab-paclitaxel - cohort 1
time frame: up to 12 months
description: TD cohort: To evaluate the safety profile of nab-paclitaxel according to CTCAE 4.0.
measure: Safety profile of nab-paclitaxel - cohort 2
time frame: up to 12 months
description: DSRCT and SE cohort: To evaluate the safety profile of nab-paclitaxel according to CTCAE 4.0.
arm group label: nab-paclitaxel
arm group type: Experimental
description: nab-paclitaxel (ABRAXANE) will be administered as follows:
Age ≥ 21: 125 mg/m2 days 1, 8 and 15 in cycles of 28 days
Age ≥ 6 months and ≤ 20 years: 240 mg/m2 (for patients weighing > 10 kg) and 11.5 mg/kg (for patients weighing ≤ 10 kg) on days 1, 8 and 15 in cycles of 28 days
intervention type: Drug
intervention name: nab paclitaxel
description: Subjects in the DT cohort will receive a maximum of three cycles. Subjects in the DSRCT and ES cohort will receive unlimited cycles until disease progression, the subject begins a new anticancer treatment, withdrawal of parent/guardian/subject consent/assent, parent/guardian/subject refusal, physician decision, toxicity that cannot be managed by dose delay or dose reduction alone or the study ends for any reason
arm group label: nab-paclitaxel
other name: Abraxane
criteria: 
gender: All
minimum age: 6 Months
maximum age: 80 Years
healthy volunteers: No
last name: Javier Martin Broto, MD
role: Study Director
affiliation: Hospitales Universitarios Virgen del Rocío
last name: Jaume Mora, MD
role: Study Director
affiliation: Hospital Sant Joan de Deu
last name: Javier Martínez Trufero, MD
role: Principal Investigator
affiliation: Hospital Miguel Servet
last name: Francisco Bautista, MD
role: Principal Investigator
affiliation: Hospital Universitario Niño Jesús
last name: Antonio López Pousa, MD
role: Principal Investigator
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
last name: Roberto Díaz, MD
role: Principal Investigator
affiliation: Hospital Universitario La Fe
last name: José Antonio López-Martín, MD
role: Principal Investigator
affiliation: Hospital Universitario 12 de Octubre
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Sarcoma
mesh term: Sarcoma, Ewing
mesh term: Fibromatosis, Aggressive
mesh term: Desmoplastic Small Round Cell Tumor
mesh term: Neuroectodermal Tumors, Primitive, Peripheral
mesh term: Paclitaxel
sharing ipd: Undecided