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A Phase II Clinical Trial of Induction Chemotherapy Regimen Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx) Followed by a Single Cycle of High Dose Chemotherapy (HDC) and Autologous Hematopoietic Stem Cell Rescue (AuHSCR) for Patients With Recurrent or Progressive Intracranial Germ Cell Tumors


Phase 2
N/A
N/A
Open (Enrolling)
Both
CNS Germ Cell Tumor

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Trial Information

A Phase II Clinical Trial of Induction Chemotherapy Regimen Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx) Followed by a Single Cycle of High Dose Chemotherapy (HDC) and Autologous Hematopoietic Stem Cell Rescue (AuHSCR) for Patients With Recurrent or Progressive Intracranial Germ Cell Tumors


Inclusion Criteria:



- ICGCT including pure germinoma and MMGCT.

- Patients with histologically proven germinoma and MMGCT, including endodermal sinus
tumor (yolk sac tumor), embryonal carcinoma, choriocarcinoma and mixed germ cell
tumor will be eligible for the study.

- Patients with mature/immature teratoma who have tumor marker elevations are eligible
on this study.

- Patient with ONLY mature and/or immature teratoma are ineligible in the absence of
the tumor marker elevations.

Exclusion Criteria:

- Patients with ICGCTs who are newly diagnosed are excluded from the study.

- Patients with the diagnosis of mature or immature teratoma in the absence of tumor
marker elevations are excluded from the study.

- Patients who are pregnant or breastfeeding are excluded from the study.

- Patients who have received previously a high dose chemotherapy regimen and autologous
transplant are excluded from this study.

- Patients who have received gemcitabine, oxaliplatin and/or paclitaxel are excluded
from this study.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response

Outcome Description:

To estimate response rate after at least two and up to four courses of induction chemotherapy with GemPOx regimen in patients with recurrent intracranial MMGCT

Outcome Time Frame:

4 months

Safety Issue:

Yes

Principal Investigator

Girish Dhall, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Hospital Los Angeles

Authority:

United States: Institutional Review Board

Study ID:

GemPOx

NCT ID:

NCT01270724

Start Date:

August 2010

Completion Date:

Related Keywords:

  • CNS Germ Cell Tumor
  • Neoplasms, Germ Cell and Embryonal

Name

Location

Children's Hospital Los AngelesLos Angeles, California  90027-0700