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Protocol No. 2006LS032 Principal Investigator McClune, Brian
Phase Phase II
Age Group Both Scope Local
Secondary Protocol No. MT2005-21
Title MT2005-21 Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors
Objective This clinical trial is studying how well a conditioning regimen, followed by one or two autologous peripheral stem cell transplants, works in treating patients with germ cell tumors.
Treatment Patients receive G-CSF subcutaneously on day 1 and continuing until stem cell collection is complete then undergo stem cell collection on day 5 of G-CSF administration and continuing for at least 3 collections until the collection goal is met. Patients who do not meet the collection goal will receive cyclophosphamide on day 1 and G-CSF on day 4 and continuing until stem cell collection is complete. Patients meeting the collection goal after PBSC mobilization undergo single or tandem stem cell transplantation. Treatments will differ for either single or tandem stem cell transplantation as described in the protocol. After completion of study treatment, patients are followed at 6, 9, and 12 months and then every 6 months for up to 2 years.
Description Giving colony-stimulating factors, such as G-CSF, and cyclophosphamide helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Tandem autologous HCT has demonstrated improvement in disease control. Our study uses two different chemotherapy regimens that kill tumor by different mechanisms to see if outcomes can be further improved.
Key Eligibility Germ cell tumor diagnosis of 1 of the following: -Poor prognosis non-seminoma germ cell tumor in ≥ first partial response (PR) or first complete response (CR), -Good or intermediate-prognosis seminoma or non-seminoma germ cell tumor in >= first PR or second CR as defined by the International Germ Cell Cancer Consensus Classification, -Increasing tumor markers only (i.e., no imaging evidence of progressive disease).
Applicable Disease Sites Any Site
Other Female Genital
Other Male Genital
Ovary
Testis
Therapies Involved Blood and Marrow Transplant
Chemotherapy
Drugs Involved CARBOPLATIN (PARAPLATIN)
ETOPOSIDE (VP-16)
FILGRASTIM (G-CSF, NEUPOGEN)
IFOSFAMIDE (IFEX, IFOS)
PACLITAXEL (TAXOL)
THIOTEPA
Status Open
Participating Institutions Masonic Cancer Center
Detailed Eligibility Patient must be between 10 and 69 years of age. History of central nervous system involvement allowed if all of the following conditions are met: -Completed treatment for CNS disease (radiotherapy, surgery, or chemotherapy); -Recovered from prior therapy; -No evidence of progressive CNS disease. * NOTE: *Patients with progressive disease by RECIST criteria and imaging techniques are not eligible to proceed to the second transplant. Other criteria as noted in protocol. Signed informed consent and HIPAA authorization required; signed assent form if patient is a minor.
Treatment Type Treatment
Contact Timothy Krepski Phone:612-273-2800
Email:tkrepsk1@fairview.org