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Tandem High-Dose Chemotherapy (HDCT) With Peripheral-Blood Stem-Cell Rescue for Patients With Metastatic Germ-Cell Tumors Failing First-Line Treatment
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. An autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. PURPOSE: This phase II trial is studying the side effects of giving high-dose chemotherapy together with stem cell transplant and to see how well it works in treating patients with metastatic germ cell tumors that have not responded to first-line therapy.
OBJECTIVES: * To evaluate the efficacy of high-dose chemotherapy comprising carboplatin and etoposide (CE) in combination with autologous hematopoietic stem cell transplantation using the CE regimen as initial salvage treatment in patients with relapsed or refractory, metastatic germ cell tumors that did not respond to first-line treatment. * To evaluate the toxicity associated with this regimen in these patients. * To evaluate biological correlates of outcome in patients with available tissue pre- and post-treatment. OUTLINE: * Conventional-dose chemotherapy: Patients receive ifosfamide on days 1 and 2, followed by cisplatin and etoposide on days 3-5, and dexamethasone on days 1-5. Patients undergo leukapheresis daily for stem cell harvest. Patients also receive conventional filgrastim (G-CSF) subcutaneously (SC) once a day beginning 48 hours after completion of chemotherapy until adequate collection of stem cells are obtained. Treatment repeats every 21 days for 1 or 2 courses. * High-dose (HD) chemotherapy: Patients receive HD carboplatin and etoposide once a day on days 1-3. Treatments repeat every 30-40 days for 2 courses. * Autologous hematopoietic stem cell transplantation: Patients undergo reinfusion of autologous stem cells on day 6 (after HD chemotherapy on days 1-5). Patients then receive one dose of pegfilgrastim SC beginning 6 hours after completion of stem cell infusion or conventional filgrastim SC once daily beginning 4 days after completion of stem cell infusion and continuing until blood counts recover.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Fondazione Istituto Nazionale dei Tumori
Milan, Italy
Start Date
October 1, 2010
Primary Completion Date
October 1, 2012
Last Updated
August 12, 2013
47
ESTIMATED participants
filgrastim
BIOLOGICAL
pegfilgrastim
BIOLOGICAL
carboplatin
DRUG
cisplatin
DRUG
dexamethasone
DRUG
etoposide
DRUG
ifosfamide
DRUG
high-dose chemotherapy with autologous stem cell rescue
OTHER
laboratory biomarker analysis
OTHER
autologous hematopoietic stem cell transplantation
PROCEDURE
peripheral blood stem cell transplantation
PROCEDURE
Lead Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
NCT00602667
NCT00683319
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07416188