Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)
This study is currently recruiting participants.
Verified February 2012 by Children's Hospital Los Angeles
Sponsor:
Children's Hospital Los Angeles
Information provided by (Responsible Party):
Girish Dhall, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier:
NCT01270724
First received: January 4, 2011
Last updated: February 16, 2012
Last verified: February 2012
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Purpose
This study will look to see how well patients with relapsed or recurrent intracranial germ cell tumors respond to the new combination of chemotherapy (in induction)of Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx) followed by consolidation chemotherapy and autologous stem cell rescue.
| Condition | Intervention | Phase |
|---|---|---|
|
CNS Germ Cell Tumor |
Drug: Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx). |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Children's Hospital Los Angeles:
Primary Outcome Measures:
- Response [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]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
Secondary Outcome Measures:
- Toxicity [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]To assess the toxicity of GemPOx regimen in all patients with ICGCT (pure germinoma and MMGCT)
| Estimated Enrollment: | 28 |
| Study Start Date: | August 2010 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx).
Two to four cycles of induction therapy with GemPOx followed by consolidation and ASCT.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01270724
Contacts
| Contact: Girish Dhall, MD | 323-361-4629 | gdhall@chla.usc.edu |
Locations
| United States, California | |
| Children's Hospital Los Angeles | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Girish Dhall, MD 323-361-8589 gdhall@chla.usc.edu | |
| Principal Investigator: Girish Dhall, MD | |
Sponsors and Collaborators
Children's Hospital Los Angeles
Investigators
| Principal Investigator: | Girish Dhall, MD | Children's Hospital Los Angeles |
More Information
No publications provided
| Responsible Party: | Girish Dhall, PI, Children's Hospital Los Angeles |
| ClinicalTrials.gov Identifier: | NCT01270724 History of Changes |
| Other Study ID Numbers: | GemPOx |
| Study First Received: | January 4, 2011 |
| Last Updated: | February 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Gemcitabine Oxaliplatin Paclitaxel Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 19, 2013