Medical Summary
The rationale for conducting this study is that for patients with locally recurrent and regionaly recurrrent head and neck cancer, there often is not a surgical procedure available for their treatment, leaving us strictly with standard chemotherapeutic agents or radiotherapy which often the patients are not candidates for or do not respond to. Because of numerous work over the years that has demonstrated a role for immunotherapy as a treetment for cancer, further studies are being done to see if head and neck cancer patients would benefit from this treatment.
The rationale for this specific study was based on previous work using injections of leukocyte interlukin perilymphatically in the necks of head and neck cancer paients with cervical recurrence. This research was able to demonstrate some response in three out or four patients tested.
The obgective of this study are to determine the toxicity of leukocyte interleukin injection, alone and in combination with immune modulation by cyclophosphamide injection, as well as indomethacin and oral zinc. The patients are those who have advanced head and neck malignancy in a recurrent fashion locally or regionally. The second objective is to determine the biologic activity of leukocyte injection to evaluate the response rate to peritumoral and intra-tumoral injection and to use the other medications of cyclophosphamide, indomethacin and zinc in the attempt to block suppressor cell activitie. The ultimate intent of the study is to obtain 20 patients that will be randomized into four groups based on the dossage of the leukocyte interleukin and to thus identify the highest dose of leukocyte interleukin where there is evidence of tumor response but no evidence of toxicity.

Lay Summary
This study is designed to find the optimal dose of interleukin injection in combination with fixed doses of chemotherapy, indocid and zinc. The dose of interleukin that the patient will be given will be 1 of 4 dose levels chosen at random. Patients with tumors that have not responded to surgery and/or radiotherapy may be eligible. Several blood tests are required prior to entering the study. Interleukin injections are given directly into the tumor everyday for 2 weeks during the first month. After the first month, the patient will again be treated with Interleukin on the same schedule as above in combination with chemotherapy and the other medications listed above. Patients will be observed for side effects as well as whether or not the tumor is responding to treatment. Patients must be prepared to travel to the hospital many times during the course of a month while they are participating in this study.

1. Over 18 years of age. .
2. Of either sex, but if female is neither pregnant nor lactating.
3. If female and of child-bearing age, is willing and able to utilize contraceptives.
4. Any squamous cell carcinoma, adenocarcinoma, or lymph-epithelioma head and neck tumor that is locally recurrent or metastatic, regardless of the site of origin, which has been initially biopsy confirmed, and which is accessible to injection. The tumor may be well-differentiated, or poorly differentiated.
5. Bidimensionally-measurable disease.
6. No brain metastatses (by clinical history).
7. Failed on therapy of higher priority.
8. Performance status 0-2.
9. Estimated life expectancy equal or greater than 3 months.
10. Acceptable hematological and chemical parameters.
11. No prior therapy with IL-2, Il-1, or any other biological response modifiers.
12. Negative HIV-antibody (HIV-1, HIV-2) test by Federally (USA) licensed ELISA.
13. Negative ciprofloxacin skin test.
14. Provided informed consent.