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High-Dose Chemotherapy and Stem Cell Transplant in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to First-Line Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01172912
Recruitment Status : Unknown
Verified August 2011 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : July 30, 2010
Last Update Posted : August 12, 2013
Information provided by:
National Cancer Institute (NCI)

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 able to replace blood-forming cells that were destroyed by chemotherapy.

PURPOSE: This phase II trial is studying the side effects of giving high-dose chemotherapy together with stem cell transplant and to see how well it works in treating patients with metastatic germ cell tumors that have not responded to first-line therapy.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Extragonadal Germ Cell Tumor Testicular Germ Cell Tumor Biological: filgrastim Biological: pegfilgrastim Drug: carboplatin Drug: cisplatin Drug: dexamethasone Drug: etoposide Drug: ifosfamide Other: high-dose chemotherapy with autologous stem cell rescue Other: laboratory biomarker analysis Procedure: autologous hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation Phase 2

Detailed Description:


  • 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 post-treatment.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 47 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tandem High-Dose Chemotherapy (HDCT) With Peripheral-Blood Stem-Cell Rescue for Patients With Metastatic Germ-Cell Tumors Failing First-Line Treatment
Study Start Date : October 2010
Estimated Primary Completion Date : October 2012

Primary Outcome Measures :
  1. Efficacy
  2. Toxicity
  3. Biological correlates of outcome

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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


  • 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)


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01172912

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Fondazione Istituto Nazionale dei Tumori Recruiting
Milan, Italy, 20133
Contact: Contact Person    39-02-2390-2532   
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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Principal Investigator: Alessandro M. Gianni, MD Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Layout table for additonal information Identifier: NCT01172912    
Other Study ID Numbers: ITA-MIL-INT-38-10
CDR0000682204 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: July 30, 2010    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: August 2011
Keywords provided by National Cancer Institute (NCI):
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
Additional relevant MeSH terms:
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Neoplasms, Germ Cell and Embryonal
Nervous System Neoplasms
Central Nervous System Neoplasms
Testicular Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Nervous System Diseases
Endocrine Gland Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Antineoplastic Agents
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic