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| Tracking Information | |||||
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| First Received Date ICMJE | February 29, 2008 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | February 2008 | ||||
| Estimated Primary Completion Date | February 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
2-year relapse-free survival rate [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00627601 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | High-Dose Chemotherapy and Stem Cell Transplant in Treating Patients With Germ Cell Tumors | ||||
| Official Title ICMJE | Tandem High Dose Chemotherapy With Autologous Hematopoietic Cell Transplant for Selected Germ Cell Cancer Patients | ||||
| Brief Summary | RATIONALE: Giving chemotherapy before a peripheral stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the 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 then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. PURPOSE: This phase II trial is studying how well giving high-dose chemotherapy together with stem cell transplant works in treating patients with germ cell tumors. |
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| Detailed Description | OBJECTIVES:
OUTLINE: Patients are stratified according to disease status (chemo-responsive first relapse vs marker negative after chemotherapy but viable tumor at surgical resection vs all other patients [second relapse, responding to third-line therapy, and no history of absolute refractoriness to platinum-based therapy] vs patients with mediastinal primary nonseminomatous germ cell tumors not in subsequent relapse and not refractory to first-line therapy) and prior therapy with paclitaxel and ifosfamide-containing regimens (yes vs no).
After completion of study treatment, patients are followed monthly for 1 year, every 2 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then yearly thereafter. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | February 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||
| Ages | 16 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00627601 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000587997, FHCRC-07156, CHNMC-07156 | ||||
| Study Sponsor ICMJE | Fred Hutchinson Cancer Research Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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