High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors

Phase 2 Completed 64 enrolled M.D. Anderson Cancer Center

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to learn if 2 cycles of high-dose chemotherapy can help to control germ-cell tumors. The first cycle of chemotherapy will include the drugs gemcitabine, docetaxel, melphalan, and carboplatin. The second cycle of chemotherapy will include the drugs ifosfamide, carboplatin, and etoposide. The safety of these drug combinations will also be studied. This is an investigational study. Gemcitabine, docetaxel, melphalan, ifosfamide, carboplatin, and etoposide are all FDA-approved and commercially available for the treatment of germ-cell tumors. Up to 67 patients will be enrolled in this study.

Timeline

Start: 2009-06-02
Primary completion: 2024-01-11
Completion: 2024-01-11

Publications

Nieto Y, Tu SM, Bassett R, Jones RB, Gulbis AM, Tannir N, Kingham A, Ledesma C, Margolin K, Holmberg L, Champlin R, Pagliaro L. Bevacizumab/high-dose chemotherapy with autologous stem-cell transplant for poor-risk relapsed or refractory germ-cell tumors. Ann Oncol. 2015 Oct;26(10):2125-32. doi: 10.1093/annonc/mdv310. Epub 2015 Jul 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	300 mg/m2	Intravenous
Subject	Carboplatin	Small molecule	333 mg/m2	Intravenous
Subject	Docetaxel	Small molecule	300 mg/m2	Intravenous
Subject	Etoposide	Small molecule	200 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	1800 mg/m2	Intravenous
Subject	Ifosfamide	Small molecule	3000 mg/m2	Intravenous
Subject	Melphalan	Small molecule	50 mg/m2	Intravenous
Background	2-MERCAPTOETHANESULFONIC ACID	Small molecule	3000 mg/m2	—

High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors

Summary

Timeline

Publications

Drugs

Indications