A trial of IRX-2 in patients with squamous cell carcinomas of the head and neck.

Abstract

A Phase II trial in 42 patients with squamous cell cancer of the head and neck (H and NSCC) was performed using a combination immunotherapy with 10-20 days of perilymphatic injections of a natural cytokine mixture (NCM: IRX-2; 200 units IL-2 equivalence) preceded by low dose cyclophosphamide (CY; 300 mg/m(2)) and followed by daily oral indomethacin (25 mg t.i.d.) and zinc (65 mg in a multivitamin preparation). Thirty-nine patients underwent subsequent surgical resection and 22 stage IV patients received additional radiotherapy. Forty-two percent were adjudged to have complete and partial clinical responses (>50% tumor reduction); an additional five patients had minor responses for a total of 58%. Comparison of post-treatment biopsies or surgical specimens showed 90% of patients had reduction in tumor area from 79% to 48% (over half of which was fragmented) and increased area of leukocyte infiltration from 9% to 32% (79% of which was lymphoid). The treatment with IRX-2 was not associated with significant side effects and 24 of patients showed improvement in eating, breathing or phonation or reduced pain and bleeding. Fifteen patients with lymphocytopenia (lymphocyte counts [LC] less than or equal to 1500 mm(3)) showed significant increases in LC, CD3+, CD4+ and CD8+ T lymphocytes of 401, 147, 95 and 100/mm(3), respectively. Analysis of outcome of 32 on protocol patients after 36 months versus 32 concurrent institutional H and NSCC controls showed delayed recurrences and significant increases in mean survival time (MST) and survival (p's<0.02). The data document immunotherapy induced regression of H and NSCC with delayed recurrence and improved mean survival time.

• Authors: J Hadden, E Verastegui, J L Barrera, M Kurman, A Meneses, J W Zinser, J de la Garza, E Hadden
• Journal: International immunopharmacology (Int Immunopharmacol) Vol. 3 Issue 8 Pg. 1073-81 (Aug 2003) ISSN: 1567-5769 [Print] Netherlands
• PMID: 12860164 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article)

Chemical References

• Cytokines
• IRX 2
• Cyclophosphamide
• Zinc
• Indomethacin

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, therapeutic use)
• Cyclophosphamide (administration & dosage)
• Cytokines (administration & dosage)
• Disease-Free Survival
• Female
• Head and Neck Neoplasms (drug therapy, immunology, mortality, pathology)
• Humans
• Immunotherapy (methods)
• Indomethacin (administration & dosage)
• Male
• Middle Aged
• Neoplasm Staging
• Neoplasms, Squamous Cell (drug therapy, immunology, mortality, pathology)
• Zinc (administration & dosage)