High-Dose Chemotherapy and Stem Cell Transplant in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to First-Line Therapy
|ClinicalTrials.gov 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
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|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||47 participants|
|Masking:||None (Open Label)|
|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|
- Biological correlates of outcome
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01172912
|Fondazione Istituto Nazionale dei Tumori||Recruiting|
|Milan, Italy, 20133|
|Contact: Contact Person 39-02-2390-2532 firstname.lastname@example.org|
|Principal Investigator:||Alessandro M. Gianni, MD||Fondazione IRCCS Istituto Nazionale dei Tumori, Milano|