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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00484601
Other study ID # JS0327
Secondary ID 03-09-11-08
Status Terminated
Phase Phase 2
First received
Last updated
Start date April 15, 2004
Est. completion date November 7, 2007

Study information

Verified date February 2019
Source Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 9
Est. completion date November 7, 2007
Est. primary completion date November 7, 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ifosfamide

Doxorubicin


Locations

Country Name City State
Singapore Johns Hopkins Singapore International Medical Center Singapore

Sponsors (1)

Lead Sponsor Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Prematured termination, data is not analysed. May 2008
Secondary To correlate EBVDNA titer with clinical response Prematured termination, data is not analysed. May 2008