Tandem high-dose chemotherapy (HDCT) with peripheral-blood stem-cell rescue for patients with metastatic germ-cell tumors failing first-line treatment. - High-dose chemotherapy for relapsed germ-cell cancer

Active, not recruiting

Conditions: Patients with metastatic germ-cell tumors failing first-line treatment.
MedDRA version: 9.1Level: LLTClassification code 10043302
MedDRA version: 9.1Level: LLTClassification code 10061378

Registration Number: EUCTR2010-021898-36-IT

Lead Sponsor: ISTITUTO NAZIONALE PER LA CURA TUMORI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

Age = 18 years Male gender Histologic or clinical diagnosis of GCT. Unequivocal progression of measurable disease (measurable disease will consist of abnormalities on 2 dimensional imaging or raised tumor markers) following one line of cisplatin-based chemotherapy. IGCCCG-2 Good, Intermediate, Poor Relapser category. WBC = 2000/?L with ANC = 1500/?L. Platelets = 100.000/?L. AST/ALT <2x ULN unless due to hepatic metastases in which case levels <5xULN are allowed. Total Bilirubin <1.5x ULN. Adequate cardiac function (EF = 50% at echocardiogram). Negative Serology for the following infectious diseases: HBV, HCV, HIV, CMV. Written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Failure to meet any of the above inclusion criteria. Patients falling into the prognostic categories of Very Good” and/or Very Poor” relapsers according to the IGCCCG-2 scoring system. More than one prior line of cisplatin-based chemotherapy. Prior treatment with high-dose chemotherapy. =7 cycles of prior cisplatin-based chemotherapy. Concurrent treatment with other cytotoxic drugs or targeted therapies. Prior radiation therapy (other than to the brain) within 14 days of day 1 of protocol chemotherapy. Inability to comply with the treatment protocol or to undergo the specified follow-up tests for safety or effectiveness. The existence of a concurrent malignancy (other than non-melanoma skin cancer). Patients with a prior malignancy, but at least 5 years since any evidence of disease will be allowed to enroll. Patients with late relapses. For high-dose cycle 2, the patient should not have evidence of progressive disease on imaging or have rapidly rising serum tumor markers following high-dose cycle 1. Serious infections (G>2 NCI-CTC v.4.0). Serum positivity for either HBV, HCV, HIV, CMV.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of high-dose chemotherapy plus stem-cell rescue (ASCT) using the carboplatin-etoposide (CE) regimen as initial salvage treatment of patients with relapsed or refractory germ-cell tumors (GCT).;Secondary Objective: To evaluate the toxicity associated with high-dose chemotherapy and ASCT using CE for patients with relapsed or refractory GCT.;Primary end point(s): 2-years Progression-free survival.

Secondary Outcome Measures