Ifosfamide and Doxorubicin in Patients With Refractory Nasopharyngeal Carcinoma

Johns Hopkins Medicine

Status and phase

Terminated

Phase 2

Conditions

Refractory Nasopharyngeal Carcinoma

Treatments

Drug: Doxorubicin

Drug: Ifosfamide

Study type

Interventional

Funder types

Other

Identifiers

NCT00484601

JS0327

03-09-11-08 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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