Table 2. Studies of NDV Oncolysates in Which Therapeutic Benefit Was Assesseda,b
| Reference Citation(s) | Type of Study | Type of Cancer | No. of Patients: Enrolled; Treated; Controlc | Strongest Benefit Reportedd | Concurrent Therapye | Level of Evidence Scoref |
| [1,2,4,11] | Phase II trial | Advanced melanoma | 32; 32; Historical controls | Improved overall survival | No | 3iiA |
| [1,2,11] | Phase II trial | Advanced melanoma | 51; 51; Historical controls | Improved overall survival | No | 3iiA |
| [6] | Phase II trial | Advanced melanoma | 24; 24; Historical controls | None | No | 3iiDi |
| [5,7] | Phase II trial | Metastatic breast or ovarian | 22; 22; None | Complete/partial tumor response, 9 patients | Yes | 3iiDiii |
| [8,12] | Phase II trial | Advanced renal cell | 208; 203; Historical controls | Improved disease-free survival | Yes | 3iiiDi |
| [9,10] | Phase I trial | Advanced melanoma | 13; 13; None | Complete tumor response, 1 patient | Yes | 3iiiDii |
| No. = number. | ||||||
| aSee text and the NCI Dictionary of Cancer Terms for additional information and definition of terms. | ||||||
| bOncolysates are prepared from virus-infected cancer cells; they consist primarily of cell membrane fragments and contain virus proteins and cancer cell proteins. | ||||||
| cNumber of patients treated plus number of patients control may not equal number of patients enrolled; number of patients enrolled = number of patients initially recruited/considered by the researchers who conducted a study; number of patients treated = number of enrolled patients who were given the treatment being studied AND for whom results were reported; historical control subjects are not included in number of patients enrolled. | ||||||
| dThe strongest evidence reported that the treatment under study has anticancer activity or otherwise improves the well-being of cancer patients. | ||||||
| eChemotherapy, radiation therapy, hormonal therapy, or cytokine therapy given/allowed at the same time as oncolysate treatment. | ||||||
| fFor information about levels of evidence analysis and an explanation of the level of evidence scores, see Levels of Evidence for Human Studies of Cancer Complementary and Alternative Medicine. |
References
- Batliwalla FM, Bateman BA, Serrano D, et al.: A 15-year follow-up of AJCC stage III malignant melanoma patients treated postsurgically with Newcastle disease virus (NDV) oncolysate and determination of alterations in the CD8 T cell repertoire. Mol Med 4 (12): 783-94, 1998. [PUBMED Abstract]
- Cassel WA, Murray DR: A ten-year follow-up on stage II malignant melanoma patients treated postsurgically with Newcastle disease virus oncolysate. Med Oncol Tumor Pharmacother 9 (4): 169-71, 1992. [PUBMED Abstract]
- Cassel WA, Murray DR, Phillips HS: A phase II study on the postsurgical management of Stage II malignant melanoma with a Newcastle disease virus oncolysate. Cancer 52 (5): 856-60, 1983. [PUBMED Abstract]
- Mallmann P: Autologous tumor-cell vaccination and lymphokine-activated tumor-infiltrating lymphocytes (LAK-TIL). Hybridoma 12 (5): 559-66, 1993. [PUBMED Abstract]
- Plager C, Bowen JM, Fenoglio C, et al.: Adjuvant immunotherapy of M.D. Anderson Hospital (MDAH) stage III-B malignant melanoma with Newcastle disease virus oncolysate. [Abstract] Proceedings of the American Society of Clinical Oncology 9: A-1091, 281, 1990.
- Mallmann P, Eis-Hubinger AM, Krebs D: Lymphokine-activated tumor-infiltrating lymphocytes and autologous tumor vaccine in breast and ovarian cancer. Onkologie 15 (6): 490-6, 1992.
- Anton P, Kirchner H, Jonas U, et al.: Cytokines and tumor vaccination. Cancer Biother Radiopharm 11 (5): 315-8, 1996. [PUBMED Abstract]
- Cassel WA, Murras DR, Torbin AH, et al.: Viral oncolysate in the management of malignant melanoma. I. Preparation of the oncolysate and measurement of immunologic responses. Cancer 40 (2): 672-9, 1977. [PUBMED Abstract]
- Murray DR, Cassel WA, Torbin AH, et al.: Viral oncolysate in the management of malignant melanoma. II. Clinical studies. Cancer 40 (2): 680-6, 1977. [PUBMED Abstract]
- Cassel WA, Murray DR: Treatment of stage II malignant melanoma patients with a Newcastle disease virus oncolysate. Nat Immun Cell Growth Regul 7 (5-6): 351-2, 1988. [PUBMED Abstract]
- Kirchner HH, Anton P, Atzpodien J: Adjuvant treatment of locally advanced renal cancer with autologous virus-modified tumor vaccines. World J Urol 13 (3): 171-3, 1995. [PUBMED Abstract]
