Tandem High-Dose Chemotherapy (HDCT) With Peripheral-Blood Stem-Cell Rescue for Patients With Metastatic Germ-Cell Tumors Failing First-Line Treatment
- 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 as initial salvage treatment in patients with relapsed or refractory,
metastatic germ cell tumors that did not respond to first-line treatment.
- To evaluate the toxicity associated with this regimen in these patients.
- To evaluate biological correlates of outcome in patients with available tissue pre- and
- Conventional-dose chemotherapy: Patients receive ifosfamide on days 1 and 2, followed
by cisplatin and etoposide on days 3-5, and dexamethasone on days 1-5. Patients undergo
leukapheresis daily for stem cell harvest. Patients also receive conventional
filgrastim (G-CSF) subcutaneously (SC) once a day beginning 48 hours after completion
of chemotherapy until adequate collection of stem cells are obtained. Treatment repeats
every 21 days for 1 or 2 courses.
- High-dose (HD) chemotherapy: Patients receive HD carboplatin and etoposide once a day
on days 1-3. Treatments repeat every 30-40 days for 2 courses.
- Autologous hematopoietic stem cell transplantation: Patients undergo reinfusion of
autologous stem cells on day 6 (after HD chemotherapy on days 1-5). Patients then
receive one dose of pegfilgrastim SC beginning 6 hours after completion of stem cell
infusion or conventional filgrastim SC once daily beginning 4 days after completion of
stem cell infusion and continuing until blood counts recover.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Alessandro M. Gianni, MD
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano