Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ifosfamide and Doxorubicin in Patients With Refractory Nasopharyngeal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00484601
Recruitment Status : Terminated (Low accrual.)
First Posted : June 11, 2007
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
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 or disease Intervention/treatment Phase
Refractory Nasopharyngeal Carcinoma Drug: Ifosfamide Drug: Doxorubicin Phase 2

Detailed Description:

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Ifosfamide and Doxorubicin in Patients With Refractory Nasopharyngeal Carcinoma
Actual Study Start Date : April 15, 2004
Actual Primary Completion Date : November 7, 2007
Actual Study Completion Date : November 7, 2007


Arm Intervention/treatment
Experimental: Ifosfamide and Doxorubicin
Single arm treatment with Ifosfamide and Doxorubicinin patients with Refractory Nasopharyngeal Carcinoma
Drug: Ifosfamide
Drug: Doxorubicin



Primary Outcome Measures :
  1. To evaluate the overall response rate and toxicity including complete response rate, response duration, time to treatment failure, and survival of ifosfamide and doxorubicin as the second line chemotherapy for patients with advanced NPC [ Time Frame: May 2008 ]
    Prematured termination, data is not analysed.


Secondary Outcome Measures :
  1. To correlate EBVDNA titer with clinical response [ Time Frame: May 2008 ]
    Prematured termination, data is not analysed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological diagnosis of NPC
  • Age > 18 years old
  • Measurable metastatic or recurrent disease (s)
  • Received one prior chemotherapy regimen for metastatic or recurrent NPC which relapsed or became refractory before entry.
  • ECOG PS 0, 1 or 2
  • WBC > 3,500/uL and ANC > 1,500/uL Platelet > 100,000/uL Creatinine - within normal limits SGOT < 3 X UNL Bilirubin < 2.0 mg/dL
  • Ejection fraction > 45% and no history of myocardial infarction or congestive heart failure in the last 6 months. No history of cardiac ventricular arrythmia or ventricle tachycardia, or uncontrolled atrial fibrillation or supraventricular tachycardia with hemodynamic compromising status.
  • Random blood glucose level < 250 mg
  • Signed informed consent

Exclusion Criteria:

  • Received more than one prior chemotherapy for metastatic or recurrent disease
  • Ejection fraction < 45%
  • WBC < 3,500/UL or ANC < 1,500/UL or P/t < 100,000/UL or SCOT> 3 x UNL or Bilirubin > 2.0 mg/dL or Creatinine > UNL
  • ECOG PS > 3
  • Hx of myocardial infarction within last 6 months
  • Random blood glucose level less than or equal 250 mg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00484601


Locations
Layout table for location information
Singapore
Johns Hopkins Singapore International Medical Center
Singapore, Singapore, 308433
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
Layout table for investigator information
Principal Investigator: Alex Chang, MD Johns Hopkins Singapore

Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00484601     History of Changes
Other Study ID Numbers: JS0327
03-09-11-08 ( Other Identifier: JHM IRB )
First Posted: June 11, 2007    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Carcinoma
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Doxorubicin
Liposomal doxorubicin
Ifosfamide
Isophosphamide mustard
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents