Status:
UNKNOWN
High-Dose Chemotherapy and Stem Cell Transplant in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to First-Line Therapy
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Conditions:
Brain and Central Nervous System Tumors
Extragonadal Germ Cell Tumor
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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:
- 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:
- HIV type 1 and 2
- Hepatitis B surface antigen (active carriers)
- Hepatitis C
- Cytomegalovirus (serum Ag p65 ± PCR confirmation at principal investigator discretion)
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior surgery
- At least 3 weeks since prior chemotherapy
- No prior high-dose chemotherapy with peripheral blood stem cell rescue
- No more than 1 prior chemotherapy regimen for metastatic disease
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01172912
Start Date
October 1 2010
Last Update
August 12 2013
Active Locations (1)
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1
Fondazione Istituto Nazionale dei Tumori
Milan, Italy, 20133