High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors
Condition: Testicular Cancer
MeSH terms: Neoplasms, Germ Cell and Embryonal; Testicular Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this clinical research study is to learn if 2 cycles of high-dose chemotherapy
      can help to control germ-cell tumors. The first cycle of chemotherapy will include the drugs
      gemcitabine, docetaxel, melphalan, and carboplatin. The second cycle of chemotherapy will
      include the drugs ifosfamide, carboplatin, and etoposide. The safety of these drug
      combinations will also be studied.

      This is an investigational study. Gemcitabine, docetaxel, melphalan, ifosfamide, carboplatin,
      and etoposide are all FDA-approved and commercially available for the treatment of germ-cell
      tumors.

      Up to 67 patients will be enrolled in this study.
    

Detailed description: 
      The Study Drugs:

      Carboplatin, melphalan, and ifosfamide are designed to damage the DNA (the genetic material)
      of cancer cells, which may cause the cancer cells to die.

      Docetaxel and etoposide are designed to stop the growth of cancer cells, which may cause the
      cancer cells to die.

      Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells
      to die. It may also help docetaxel, carboplatin, and melphalan to be more effective by
      stopping tumor cells from repairing damage caused by these drugs.

      Study Drug Administration:

      You will receive 2 cycles of high-dose chemotherapy with stem-cell support, 1-2 months apart.

      Starting on the first day of your hospital stay, you will begin gargling and swishing
      Caphosol and Glutamine in your mouth 4 times a day. This is done to help prevent mouth and
      throat sores.

      On Day 2 of your stay in the hospital, through the CVC, you will receive gemcitabine over 4
      hours and docetaxel over 2 hours.

      On Days 3-5, through the CVC, you will receive gemcitabine over 4 hours, melphalan over 15
      minutes, and carboplatin over 2 hours.

      On Day 6, you will not receive any study drugs.

      On Day 7, you will receive the stem cells through the CVC over about 30-60 minutes.

      As part of standard care, you will receive G-CSF (filgrastim) as an injection under your skin
      daily, starting 5 days after the transplant, until your blood cell levels return to normal.

      As part of standard mouth care you will be asked to do mouthwashes 4 times a day with
      caphosol (artificial saliva) and glutamine.

      Two (2) to 4 weeks after you leave the hospital after Cycle 1, you will receive your second
      cycle of high-dose chemotherapy.

      On Days 2-4 of your stay in the hospital, through the CVC, you will receive ifosfamide over 6
      hours, etoposide over 2 hours, and carboplatin over 2 hours.

      On Days 5-6, you will not receive any study drugs.

      On Day 7, you will receive the stem cells through the CVC over about 30-60 minutes.

      Study Visits:

      About 1 month, 100 days, 6 months and 1 year after your second stem cell transplant, the
      following tests and procedures will be performed:

        -  To check the status of the disease, you will have CT scans of your chest, abdomen, and
           pelvis.

        -  Blood (about 3 tablespoons) will be drawn for routine tests.

      Length of Study:

      You will be off study after about 1 year from your second transplant. You will be taken off
      study early if the disease gets worse or if you experience any intolerable side effects.

      Long-Term Follow-up:

      If your doctor thinks it is needed, you may have follow-up visits.
    

Intervention name(s): Gemcitabine; Docetaxel; Melphalan; Carboplatin; Mesna; Ifosfamide; Etoposide; Stem Cell Transplant
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Procedure
Intervention description(s): 1800 mg/m^2 IV over 3 hours on Days -5 to Day -2.; Docetaxel 300 mg/m^2 IV over 2 hours on Day -5.; 50 mg/m^2 IV over 15 minutes on Days -4 to Day -2.; Cycle 1: 333 mg/m^2 IV over 2 hours on Days -4 to -2.
Cycle #2: 300 mg/m^2 IV over 2 hours on Days -6 to -3.; 3,000 mg/m^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4.; 3,000 mg/m^2 IV over 6 hours on Days -6 to -3; 200 mg/m^2 IV over 3 hours, every 12 hours on Days -6 to -4.; Stem cell infusion on Day 0.
Other intervention name(s): Gemcitabine Hydrochloride; Gemzar; Taxotere; Alkeran; Paraplatin; Mesnex; Ifex; VePesid; SCT; Hematopoietic progenitor-cell infusion; PBPC
Intervention MeSH terms: Carboplatin; Gemcitabine; Docetaxel; Etoposide; Melphalan; Ifosfamide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Testis; Relapsed Testicular Cancer; Bevacizumab; Avastin; Anti-VEGF monoclonal antibody; rhuMAb-VEGF; Carboplatin; Paraplatin; Docetaxel; Taxotere; Etoposide; VePesid; Gemcitabine; Gemcitabine Hydrochloride; Gemzar; Ifosfamide; Ifex; Melphalan; Alkeran