Claims for Patent: 5,484,596

Summary for Patent: 5,484,596

Title:	Active specific immunotherapy
Abstract:	This invention relates to a method of cancer therapy for treating human patients with resectable solid tumors to inhibit recurrence and formation of metastases, comprising surgically removing tumor tissue from a human cancer patient, treating the tumor tissue to obtain tumor cells, irradiating the tumor cells to be viable but non-tumorigenic, preparing a vaccine comprising about 10.sup.7 viable but non-tumorigenic tumor cells per dose and injecting the vaccine intradermally into the human patient after the patient\'s immune system has recovered from surgery.
Inventor(s):	Hanna, Jr.; Michael G. (Frederick, MD), Hoover, Jr.; Herbert C. (Hingham, MA), Peters; Leona C. (Frederick, MD)
Assignee:	Akzo N.V. (Arnhem, NL)
Application Number:	08/122,257
Patent Claims:	1. A method of cancer therapy for treating a human patient with a resectable, solid carcinoma tumor to inhibit recurrence or formation of metastases, comprising surgically removing solid tumor tissue from a human cancer patient and preparing a viable autologous tumor cell vaccine by treating the tumor tissue to obtain viable tumor cells by the method of digesting tumor tissue with collagenase to free tumor cells, whereby said cells remain viable and intact, irradiating the tumor cells to be viable but non-tumorigenic, preparing a vaccine comprising about 10.sup.7 viable but non-tumorigenic tumor cells per dose and injecting at least three doses of the vaccine intradermally into the human patient from whom the tumor tissue had been removed after the patient's immune system has recovered from surgery, wherein at least the first two of the at least three doses comprise about 10.sup.7 BCG cells as adjuvant and the last dose is free of adjuvant, and wherein at the time of injection cell viability is at least 70% when measured by trypan blue exclusion testing. 2. The therapeutic method of claim 1, wherein the cancer patient is inoculated with said vaccine once each week for at least three weeks. 3. The therapeutic method of claim 1, wherein the patient is injected once each week for two weeks with said vaccine comprising about 10.sup.7 BCG cells, and a third vaccination is performed with said vaccine comprising about 10.sup.7 deactivated tumor cells but no BCG cells. 4. The therapeutic method of claim 1, wherein the tumor cells are deactivated by irridation with a total of about 20,000 rads. 5. The therapeutic method of claim 1, wherein the viability of the deactivated tumor cells is in the range of about 70 to 90% when measured by trypan blue exclusion testing. 6. The therapeutic method of claim 1, wherein the tumor cells are obtained from tumor tissue by the method of disecting the tumor tissue to remove extraneous tissue, mincing the tumor tissue into tissue fragments and digesting the tumor tissue fragments. 7. The therapeutic method of claim 1, wherein the tumor cells are cryopreserved after digestion until time for injecting said vaccine into the patient, at which time the cryopreserved tumor cells are rapidly thawed and deactivated by irridation, and wherein the cells are cryopreserved by controlled rate freezing at about -1.degree. C./min. to a temperature of about -80.degree. C. 8. The therapeutic method of claim 1, wherein recovery of the patient's immune system after surgery is tested by skin testing. 9. The therapeutic method of claim 1, wherein the patient is injected with said vaccine beginning 3 to 5 weeks after surgical removal of the tumor.

Details for Patent 5,484,596

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2013-01-16