ARAR0331: Treatment of Childhood Nasopharyngeal Carcinoma with Neoadjuvant Chemotherapy and Concomitant Chemoradiotherapy

Summary

The subject will be treated in 1 of 2 ways depending on the stage of the disease:

* Treatment Group 1: Subjects with early stages of disease will get radiation therapy only.

* Treatment Group 2: Subjects with advanced disease, or disease that has spread, will first get chemotherapy alone and then get a combination of chemotherapy and radiation therapy.

Treatment Group 1
Subjects will get radiation therapy to the head and neck 5 days a week for about 7 or 8 weeks. They will also get the drug amifostine every day before getting radiation therapy. Amifostine will be given by an injection under the skin 15-30 minutes before radiation therapy starts. Some larger subjects will get 2 doses a day.

Treatment Group 2
Subjects will first get Induction therapy, over a period of 9 weeks, in order to shrink the tumor. Then they will get Consolidation therapy, also over a period of about 9 weeks.
The subjects study doctor will evaluate them after Induction therapy and after Consolidation therapy. If surgery could be used to remove the tumor this will be discussed with the subject.

Induction therapy:
Induction therapy will be 3 cycles of chemotherapy. Each cycle will last 21 days. You will receive the drugs cisplatin (on Day 1 of each cycle) and 5-fluorouracil (on Days 1 to 4 of each cycle).

Consolidation therapy:
The chemotherapy part will be 2 cycles of cisplatin that last 21 days each. While the subject is getting chemotherapy he/she will also get radiation therapy to the head and neck area. This radiation therapy will be given 5 days a week for about 7 to 8 weeks. The amount of radiation therapy received will depend upon how well the tumor responds to Induction therapy.

On the days the subject gets radiation therapy he/she will also get the drug amifostine. Amifostine will be given by an injection under the skin 15-30 minutes before radiation therapy starts. Some larger subjects will get 2 doses a day.

Participant Eligibility

1) Patients must be less than 19 years of age at the time of diagnosis. 2) Newly diagnosed patients with histological diagnosis of nasopharyngeal carcinoma WHO Type II or III and specimens for rapid central review of the diagnostic material must be sent within 72 hours of study enrollment. 3) Performance Level for patients ≤ 16 years of age: Lansky ≥ 60%, Patients > 16 years of age: Karnofsky ≥ 60%. 4) The patient must have received no previous chemotherapy or radiotherapy to the nasopharynx or neck for the treatment of nasopharyngeal carcinoma. 5) Adequate renal function defined:
- Creatinine clearance or radioisotope GFR ≥ 70mL/min/1.73m2 OR
- A serum creatinine based on age/gender
6) Adequate liver function defined as:
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age, and
- SGOT (AST) or SGPT (ALT) < 2.5 x upper limit of normal (ULN) for age.
7) Other Criteria: Since there is no available information, as yet, regarding human fetal or teratogenic toxicities, the following restriction apply:
• Female patients of childbearing potential must have a negative pregnancy test.
• Lactating females must agree that they will not breastfeed a child while on this study.
• Males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
8) Spanish speaking subjects are eligible to participate in this study.