Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Sidney Kimmel Comprehensive Cancer Center |
---|---|
Information provided by: | Sidney Kimmel Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00484601 |
This research is to test the effectiveness and toxicity of both Ifosfamide and Doxorubicin. It also aims to explore the relationship between EBV DNA and clinical response in patients with advanced naso-pharyngeal cancer which has been previously treated with chemotherapy.
Condition | Intervention | Phase |
---|---|---|
Refractory Nasopharyngeal Carcinoma |
Drug: Ifosfamide; Doxorubicin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Study of Ifosfamide and Doxorubicin in Patients With Refractory Nasopharyngeal Carcinoma |
Estimated Enrollment: | 35 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | September 2010 |
Nasopharyngeal Cancer (NPC) is one of the common cancer in Southeast Asia. In this region NPC is associated with Epstein Barr Virus (EBV) chronic infection with EBV DNA identifiable in almost all the NPC tumors and patient's serum at the time of diagnosis. Chinese, especially cantonese has the highest incidence. Only about 30% of patients presents early disease and has a good treatment outcome (80% cure for stage I disease and 70% for stage II by radiation).
This research is to test the effectiveness and toxicity of both Ifosfamide and Doxorubicin. It also aims to explore the relationship between EBV DNA and clinical response in patients with advanced naso-pharyngeal cancer which has been previously treated with chemotherapy.
Investigators believe EBV infection is necessary to cause NPC and that EBV DNA levels in the blood may directly relate to the total size of the tumor. Because NPC patients in this situation have a poor outlook, we design this study to evaluate the combination of Ifosfamide and doxorubicin for further treatment. While this combination of medicines has been used in many other forms of cancer, it has not been tested in patients with NPC.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Singapore | |
Johns Hopkins Singapore International Medical Center | |
Singapore, Singapore, 308433 |
Principal Investigator: | Alex Chang, MD | Johns Hopkins SIngapore International Medical Center |
Responsible Party: | Johns Hopkins Singapore International Medical Centre ( Alex Chang, M.D ) |
Study ID Numbers: | JS0327, 03-09-11-08 |
Study First Received: | June 8, 2007 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00484601 |
Health Authority: | United States: Institutional Review Board; Singapore: Domain Specific Review Boards; Singapore: Health Sciences Authority |
Otorhinolaryngologic Neoplasms Otorhinolaryngologic Diseases Pharyngeal Neoplasms Pharyngeal Diseases Nasopharyngeal Neoplasms Doxorubicin Carcinoma |
Ifosfamide Nasopharyngeal carcinoma Mechlorethamine Head and Neck Neoplasms Stomatognathic Diseases Neoplasms, Glandular and Epithelial Isophosphamide mustard |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Nasopharyngeal Diseases Antineoplastic Agents, Alkylating Antibiotics, Antineoplastic Alkylating Agents Pharmacologic Actions |