Phase I–II study of intratumor immunotherapy with BCG cell wall skeleton plus P3

✍ Scribed by S. P. Richman; J. U. Gutterman; E. M. Hersh; E. E. Ribi

• Publisher: Springer-Verlag
• Year: 1978
• Tongue: English
• Weight: 335 KB
• Volume: 5
• Category: Article
• ISSN: 0340-7004
• DOI: 10.1007/bf00199206

✦ Synopsis

A vaccine composed of BCG cell wall skeleton (CWS) and a trehalose dimycolate called P3, attached to microdroplets of mineral oil, was evaluated for activity and toxicity when injected into tumor nodules. A total of 99 nodules in 23 patients with metastatic melanoma and carcinoma of the breast were treated over a dose range of 150 ~g, 300 ~g, and 600 ~g cell wall skeleton plus P3 per cm of nodule diameter. At least one injected nodule resolved in 11 of the 23 patients (48%), and 34% of all injected nodules resolved. Response correlated with nodule size of 1 cm or less, cutaneous location, and immunocompetence measured by PPD and recall skin testing. Toxicity became manifest in ulceration (61% of patients), fever (52%), and pain (26%).