Germ Cell Tumor
Conditions
Keywords
Patients with relapsed non-seminomatous germ-cell tumors (NSGCT)
Brief summary
This is a prospective multicenter phase II trial of gemcitabine, cisplatin, and ifosfamide (GIP) in patients with relapsed non-seminomatous germ-cell tumors (NSGCT) and a predicted favorable prognosis.
Interventions
DRUGgemcitabine, ifosfamide, cisplatin, G-CSF
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than 16 years * Histologically-proven disseminated (non stage I) NSGCT, or diagnosis of NSGCT based on very elevated serum human chorionic gonadotropin (HCG) and/or alpha fetoprotein (AFP) * Relapsed disease classified as good prognosis according to the Memorial Sloan-Kettering Cancer Center (MSKCC) classification criteria: * Testicular primary site * Prior treatment limited to one program (or 6 or fewer cycles of cisplatin) * Either a complete response or a partial response with normal serum AFP and HCG * Relapse documented by rising AFP and/or HCG or by a biopsy * No previous carcinoma, except basal-cell carcinoma of the skin * Adequate renal function: measured or calculated creatinine clearance\> 60 ml/min * Absolute granulocyte count \>= 1,500/mm3, platelets \>= 100,000 mm3, bilirubin \< 1.5 fold the upper normal value * Signed informed consent.
Exclusion criteria
* Patients infected by the human immunodeficiency virus (HIV) * Patients who do not fit inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity | — |
| Progression free survival | — |
| Overall survival | — |
Countries
France
Contacts
Primary ContactKarim FIZAZI, Dr
Outcome results
None listed