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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000682204 | Registry Identifier | PDQ (Physician Data Query) | |
| EUDRACT-2010-021898-36 | |||
| EU-21054 |
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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:
OUTLINE:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | |||
| pegfilgrastim | Biological | |||
| carboplatin | Drug | |||
| cisplatin | Drug | |||
| dexamethasone | Drug | |||
| etoposide | Drug | |||
| ifosfamide | Drug | |||
| high-dose chemotherapy with autologous stem cell rescue |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | ||
| Toxicity | ||
| Biological correlates of outcome |
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DISEASE CHARACTERISTICS:
Histologically confirmed germ cell tumor (GCT) based on pathologic review at INT Milan
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:
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
PATIENT CHARACTERISTICS:
WBC ≥ 2,000/µL
ANC ≥ 1,500/µL
Platelet count ≥ 100,000/µL
Creatinine clearance ≥ 50 cc/min (unless renal dysfunction is due to tumor obstructing the ureters, in which case eligibility will be determined by the principal investigator)
AST/ALT < 2 times upper limit of normal (ULN) (< 5 times ULN if due to hepatic metastases)
Total bilirubin < 1.5 times ULN
Ejection fraction ≥ 50% by echocardiogram
Negative serology for the following infectious diseases:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Alessandro M. Gianni, MD | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Istituto Nazionale dei Tumori | Recruiting | Milan | 20133 | Italy |
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| Other |
| laboratory biomarker analysis | Other |
| autologous hematopoietic stem cell transplantation | Procedure |
| peripheral blood stem cell transplantation | Procedure |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| C563236 | Testicular Germ Cell Tumor |
| D013736 | Testicular Neoplasms |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004700 | Endocrine System Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| C455861 | pegfilgrastim |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D003907 | Dexamethasone |
| D005047 | Etoposide |
| D007069 | Ifosfamide |
| D004358 | Drug Therapy |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D003520 | Cyclophosphamide |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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