This phase II trial studies how well high-dose chemotherapy, bevacizumab, and stem cell transplant work in treating patients with germ cell tumors that have come back. Giving chemotherapy before a stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. Also, monoclonal antibodies, such as bevacizumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00936936.
PRIMARY OBJECTIVES:
I. To derive estimates of the event-free survival (EFS) in the bevacizumab and non-bevacizumab cohorts.
SECONDARY OBJECTIVES:
I. To estimate the response rate (RR) and complete response (CR) rate among patients with measurable disease in both cohorts.
II. To describe the side effect profiles of bevacizumab/gemcitabine (gemcitabine hydrochloride)/docetaxel/melphalan/carboplatin; bevacizumab/ifosfamide/carboplatin/etoposide; and gemcitabine/docetaxel/melphalan/carboplatin and ifosfamide/carboplatin/etoposide; extramedullary side effects, engraftment rate.
III. To estimate the overall survival (OS) in both cohorts.
IV. To compare the EFS in both cohorts.
OUTLINE:
COHORT I (COURSE 1) (Closed as of December 2014): Patients receive bevacizumab intravenously (IV) over 90 minutes on day -14, gemcitabine hydrochloride IV over 3 hours on days -5 to -2, docetaxel IV over 2 hours on day -5, melphalan IV over 15 minutes and carboplatin IV over 2 hours on days -4 to -2, and undergo autologous peripheral blood stem cell transplant on day 0.
COHORT I (COURSE 2): Patients receive bevacizumab IV over 90 minutes on day -15, ifosfamide IV over 6 hours on days -6 to -3, etoposide IV over 3 hours every 12 hours or etoposide phosphate IV over 3 hours every 12 hours on days -6 to -4, carboplatin IV over 2 hours on days -6 to -3, and undergo autologous peripheral blood stem cell transplant on day 0.
COHORT II (COURSE 1): Patients receive gemcitabine hydrochloride IV over 3 hours on days -5 to -2, docetaxel IV over 2 hours on day -5, melphalan IV over 15 minutes and carboplatin IV over 2 hours on days -4 to -2, and undergo autologous peripheral blood stem cell transplant on day 0.
COHORT II (COURSE 2): Patients receive ifosfamide IV over 6 hours on days -6 to -3, etoposide IV over 3 hours every 12 hours or etoposide phosphate IV over 3 hours every 12 hours on days -6 to -4, carboplatin IV over 2 hours on days -6 to -3, and undergo autologous peripheral blood stem cell transplant on day 0.
During both courses, treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 month, 100 days, 6 months, and 1 year.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorYago L. Nieto
