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Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors

A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) With High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors

  • Clinical Trial Information

    Trial Contact: El-Shami, Jessica; Leffin, Melissa; Cevallos, Claudia; Spinelli, Jennifer

  • IRB No: A031102

    Protocol Abbrev: A031102

    Principal Investigator: Amy A Smith, MD

    Phase: Drug: Phase III

    Age Group: Adult;Pediatric

    Secondary Protocol No: A031102

    Treatment: Drug: paclitaxel, Drug: ifosfamide, Drug: cisplatin, Drug: pegylated G-CSF, Drug: G-CSF, Drug: carboplatin, Drug: etoposide phosphate, Procedure: stem cell reinfusion

    Therapies Involved: Chemotherapy;Procedural

    ClinicalTrials.gov ID: NCT02375204

  • Objective

    To compare the overall survival in patients treated with conventional-dose chemotherapy using the TIP regimen with high-dose chemotherapy (HDCT) plus autologous stem cell transplant (ASCT) using the TI-CE regimen as initial salvage treatment of patients with relapsed or refractory germ cell tumors (GCT)

  • Key Eligibility

    Ages Eligible for Study: 14 Years and older (Child, Adult, Older Adult)
    Sexes Eligible for Study: Male
    Accepts Healthy Volunteers: No