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Tandem High-Dose Chemotherapy (HDCT) With Peripheral-Blood Stem-Cell Rescue for Patients With Metastatic Germ-Cell Tumors Failing First-Line Treatment

Phase 2
18 Years
Open (Enrolling)
Brain and Central Nervous System Tumors, Extragonadal Germ Cell Tumor, Testicular Germ Cell Tumor

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Trial Information

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.

Inclusion Criteria


- Histologically confirmed germ cell tumor (GCT) based on pathologic review at INT

- 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


- 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

- 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


- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Safety Issue:


Principal Investigator

Alessandro M. Gianni, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano



Study ID:




Start Date:

October 2010

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Extragonadal Germ Cell Tumor
  • Testicular Germ Cell Tumor
  • recurrent extragonadal germ cell tumor
  • recurrent extragonadal non-seminomatous germ cell tumor
  • recurrent malignant testicular germ cell tumor
  • stage IV extragonadal non-seminomatous germ cell tumor
  • stage III malignant testicular germ cell tumor
  • recurrent extragonadal seminoma
  • stage IV extragonadal seminoma
  • testicular mature teratoma
  • adult central nervous system germ cell tumor
  • testicular immature teratoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Neoplasms, Germ Cell and Embryonal