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NCT00002931 · FLOW

Participant flow

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Germ Cell Cancer · Source last updated 2017-02-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
    id
    FG000
    title
    HD Chemo and Auto Stem Cells
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      rapidly progressing disease during
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        48
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        46
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
    id
    FG000
    title
    HD Chemo and Auto Stem Cells
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      rapidly progressing disease during
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        48
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        46
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice