Skip to main content
SpringerLink
Log in

Randomized clinical study on intratumoral BCG-cell wall preparation (CWP) therapy in patients with squamous cell carcinoma in the head and neck region

  • Original Articles
  • Published:
Cancer Immunology, Immunotherapy Aims and scope Submit manuscript

Summary

Based on animal experiments a clinical study with BCG cell wall preparation (CWP) was developed. Patients with head and neck carcinomas stage T1/2N0–2M0 were randomized. One group received surgical treatment only and a second group received preoperative intralesional BCG-CWP. So far 12 patients have been included in each group. After 3 years the CCR (complete cancer remission) in the surgery only group was 39% and that in the preoperative BCG-CWP group, 69% (P=11%). The cumulative proportion of surviving patients was 50% in the surgery only and 73% in the BCG-CWP group (P=21%). BCG-CWP injection was followed by an increase in body temperature and a decrease in peripheral blood lymphocytes. No changes in liver, kidney, or other organ function could be observed after BCG-CWP therapy. Complications and severe secondary effects such as have been described for living BCG were not observed, and significant immunological changes have not been detected so far.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Aungst CW, Sokal JE, Jager BV (1975) Complications of BCG vaccination in neoplastic disease. Ann Intern Med 82:666

    Google Scholar 

  2. Bodurtha A, Kim YH, Laucius JF (1974) Hepatic granulomas and other hepatic lesions associated with BCG immunotherapy for cancer. Am J Clin Pathol 61:747

    Google Scholar 

  3. Bornstein RS, Mastrangelo MJ, Sulit H (1973) Immunotherapy of melanoma with intralesional BCG. Natl Cancer Inst Monogr 39:213

    Google Scholar 

  4. Cohen MH, Jessup JM, Felix EL (1978) Intralesional treatment of recurrent metastatic cutaneous malignant melanoma. Cancer 41:2456

    Google Scholar 

  5. Cutler SJ, Ederer F (1958) Maximum utilization of the life table method in analyzing survival. J Chronic Dis 8:699

    Google Scholar 

  6. Epstein WL, Klingman AM (1958) The interference phenomenon in allergic contact dermatibilis. J Invest Dermatol 31:103

    Google Scholar 

  7. Everall JB, Wand J, O'Doherty CJ, Dowd PM (1975) Treatment of primary melanoma by intralesional vaccina before excision. Lancet II:583

    Article  Google Scholar 

  8. Grant RM, Cochran AJ, Mackie R (1974) Results of administering BCG to patients with melanoma. Lancet II:1096

    Google Scholar 

  9. Hanna MG, Zbar B, Rapp HJ (1972) Histopathology of tumor regression after intralesional injection of Mycobacterium bovis. I. Tumor growth and metastasis. J Natl Cancer Inst 48:1441

    Google Scholar 

  10. Hunt JS, Silverstein MJ, Sparks F (1973) Granulomatous hepatitis: A complication of BCG immunotherapy. Lancet II:820

    Google Scholar 

  11. Kleinschuster SJ, Rapp HJ, Lueker DC, Kainer R (1977) Regression of bovine ocular carcinoma by treatment with a mycobacterial vaccine. J Natl Cancer Inst 58:1807

    Google Scholar 

  12. Krementz ET, Samuels MS, Wallace JH (1971) Clinical experiences in immunotherapy of cancer. Surg Gynecol Obstet 133:209

    Google Scholar 

  13. Krown SE, Hilal EY, Pinsky CM (1978) Intralesional injection of the methanol extraction residue of Bacillus Calmette-Guérin (MER) into cutaneous metastases of malignant melanoma. Cancer 42:2648

    Google Scholar 

  14. Levy NL, Mahaley MS, Day ED (1972) Serum-mediated blocking of cell-mediated anti-tumor immunity in a melanoma patient: Association with BCG immunotherapy and clinical deterioration. Int J Cancer 10:244

    Google Scholar 

  15. Liebermann R, Wybran J, Epstein W (1975) The immunologic and histopathologic changes of BCG-mediated tumor regression in patients with malignant melanoma. Cancer 35:756

    Google Scholar 

  16. Mansell PWA, Krementz ET (1973) Reactions to BCG. JAMA 226:1570

    Google Scholar 

  17. Mastrangelo M, Bornstein RS, Sulit H (1972) Immunotherapy of malignant melanoma. Ann Intern Med 76:877

    Google Scholar 

  18. Mastrangelo MJ, Kim YH, Bornstein RS (1974) Clinical and histologic correlation of melanoma regression after intralesional BCG therapy. J Natl Cancer Inst 52:19

    Google Scholar 

  19. Mastrangelo MJ, Bellet RE, Berkelhammer J (1975) Regressions of pulmonary metastatic disease associated with intralesional BCG therapy of intracutaneous melanoma metastases. Cancer 36:1305

    Google Scholar 

  20. Mastrangelo MJ, Sulit HL, Prehn LM (1976) Intralesional BCG in the treatment of metastatic malignant melanoma. Cancer 37:684

    Google Scholar 

  21. McKhann CF, Hendrickson CG, Spilter LE (1975) Immunotherapy of melanoma with BCG: Two fatalities following intralesional injection. Cancer 25:514

    Google Scholar 

  22. McKneally MF, Maver C, Kausel HW (1976) Regional immunotherapy of lung cancer with intrapleural BCG. Lancet I:377

    Article  Google Scholar 

  23. Morton DL (1971) Immunological studies with human neoplasms. J Reticuloendothel Soc 10:137

    Google Scholar 

  24. Morton DL, Eilber FR, Joseph WL (1970) Immunologic factors in human sarcomas and melanomas: A rational basis for immunotherapy. Ann Surg 172:740

    Google Scholar 

  25. Morton DL, Holmes EC, Eilber FR (1971) Immunological aspects of neoplasia: A rational basis for immunotherapy. Ann Intern Med 74:587

    Google Scholar 

  26. Morton DL, Eilber FR, Holmes EC (1974) BCG immunotherapy of malignant melanoma: Summary of a seven-year experience. Ann Surg 180:635

    Google Scholar 

  27. Nathanson L (1972) Regression of intradural malignant melanoma following intralesional injection of Mycobacterium bovis strain BCG. Cancer Chemother Rep 56:659

    Google Scholar 

  28. Norton JA, Shulman NR, Corash L (1978) Severe thrombocytopenia following intralesional BCG therapy. Cancer 41:820

    Google Scholar 

  29. Pinsky MC, Hirshaut Y, Oettgen HF (1973) Treatment of malignant melanoma by intratumoral injection of BCG. Natl Cancer Inst Monogr 39:225

    Google Scholar 

  30. Richman SP, Mavligit GM, Wolk R (1975) Epilesional scarification. JAMA 234:1233

    Google Scholar 

  31. Richman SP, Guttermann JU, Hersh EM, Ribi EE (1978) Phase I–II study of intratumor immunotherapy with BCG cell wall skeleton plus P3. Cancer Immunol Immunother 5:41

    Google Scholar 

  32. Robinson JC (1977) Risks of BCG intralesional therapy: An experience with melanoma. J Surg Oncol 9:587

    Google Scholar 

  33. Rosenberg E, Powell R (1973) Active tumor immunotherapy with BCG. South Med J 66:1359

    Google Scholar 

  34. Rosenberg SA, Rapp HJ (1976) Intralesional immunotherapy of melanoma with BCG. Med Clin North Am 60:419

    Google Scholar 

  35. Rosenberg SA, Seipp C, Sears HF (1978) Clinical and immunologic studies of dissemenated BCG infection. Cancer 41:1771

    Google Scholar 

  36. Seigler HF, Shingleton WW, Metzgar RS (1973) Immunotherapy in patients with melanoma. Ann Surg 178:352

    Google Scholar 

  37. Smith GV, Morse PA Jr, Derlaps DG (1973) Immunotherapy of patients with cancer. Surgery 74:59

    Google Scholar 

  38. Sparks FC (1976) Hazards and complications of BCG immunotherapy. Med Clin North Am 60:499

    Google Scholar 

  39. Sparks FC, Silverstein MJ, Hunt JS (1973) Complications of BCG immunotherapy in patients with cancer. N Engl J Med 289:827

    Google Scholar 

  40. Sparks FC, Highton A, Hunt JS (1975) Generalized reaction associated with the intratumor injection of BCG. Chest 68:725

    Google Scholar 

  41. Vosika G, Schmidtke J, Goldman (1979) Phase I–II study of intralesional immunotherapy with oil-attached Mycobacterium smegmatis cell wall skeleton and trehalose dimycolate. Cancer Immunol Immunother 6:135

    Google Scholar 

  42. Yamamura Y, Azuma I, Taniyama T (1976) Immunotherapy of cancer with cell wall skeleton of Mycobacterium bovis — Bacillus Calmette-Guérin. Ann NY Acad Sci 277:209

    Google Scholar 

  43. Yarkoni E, Rapp HJ, Zbar B (1977) Immunotherapy of a guinea pig hepatoma with ultrasonically prepared Mycobacterial vaccines. Cancer Immunol Immunother 2:143

    Google Scholar 

  44. Zbar B, Ribi EE, Meyer T, Azuma I, Rapp HJ (1974) Immunotherapy of cancer: regression of established intradermal tumor after intralesional injection of mycobacterial cell walls attached to oil droplets. J Natl Cancer Inst 52:1571

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Maxillo-Facial and Plastic Surgery of the Face, Klinikum Steglitz, Free University of West Berlin, Hindenburgdamm 30, 1000, Berlin 45, Federal Republik of Germany

    Jürgen Bier

  2. Laboratory of Immunobiology, Division of Cancer Biology and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, Maryland

    Herb J. Rapp, Tibor Borsos & Bert Zbar

  3. Department of Animal, Dairy and Veterinary Sciences, Utah State University, Logan, Utah, USA

    Steve Kleinschuster

  4. Institute for Medical Microbiology, University of Mainz, Federal Republic of Germany

    Hermann Wagner & Martin Röllinghoff

Authors
  1. Jürgen Bier
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Herb J. Rapp
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Tibor Borsos
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Bert Zbar
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Steve Kleinschuster
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Hermann Wagner
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Martin Röllinghoff
    View author publications

    You can also search for this author in PubMed Google Scholar

Rights and permissions

Reprints and permissions

About this article

Cite this article

Bier, J., Rapp, H.J., Borsos, T. et al. Randomized clinical study on intratumoral BCG-cell wall preparation (CWP) therapy in patients with squamous cell carcinoma in the head and neck region. Cancer Immunol Immunother 12, 71–79 (1981). https://doi.org/10.1007/BF00200315

Download citation

  • Received:

  • Accepted:

  • Issue Date:

  • DOI: https://doi.org/10.1007/BF00200315

Keywords

Search

Navigation