High-Dose Chemotherapy and Stem Cell Transplant in Treating Patients With Metastatic Germ Cell Tu… (NCT01172912) | Clinical Trial Compass
UnknownPhase 2
High-Dose Chemotherapy and Stem Cell Transplant in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to First-Line Therapy
Italy47 participantsStarted 2010-10
Plain-language summary
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.
Who can participate
Age range18 Years
SexMALE
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DISEASE CHARACTERISTICS:
* Histologically confirmed germ cell tumor (GCT) based on pathologic review at INT Milan
* Metastatic disease
* Relapsed or refractory disease
* Prior chemotherapy treatment for GCT without a pathologic diagnosis due to unequivocal clinical evidence of GCT and an urgent need to start therapy (elevated alpha-fetoprotein \[AFP\] or human chorionic gonadotropin \[HCG\] with pattern of metastases consistent with GCT and high tumor burden) allowed
* Unequivocal progression of measurable disease, consisting of abnormalities on 2-dimensional imaging or raised tumor markers, following 1 line of cisplatin-based chemotherapy as documented by either of the following:
* Tumor biopsy of new, growing, or unresectable lesions demonstrating viable non-teratomatous GCT (enrollment on this study for adjuvant treatment after resection of viable GCT not allowed)
* Increasing or abnormally elevated serum tumor markers (HCG or AFP) (increasing lactate dehydrogenase \[LDH\] alone does not constitute progressive disease)
* Received ≥ 3 and ≤ 6, cisplatin-based chemotherapy courses as part of first-line (initial) chemotherapy and ≤ 6 cisplatin-based chemotherapy courses
* Brain metastases allowed
* May be treated with radiotherapy and/or surgery concurrently with cisplatin, ifosfamide, and etoposide regimen
* Radiotherapy should not be given concurrently with mobilization phase/leukapheresis and high-dose carboplatin and etoposide
PATIENT CHARACTERISTICS:
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What they're measuring
1
Efficacy
2
Toxicity
3
Biological correlates of outcome
Trial details
NCT IDNCT01172912
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano