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|
Table 2. Studies of NDV Oncolysates in Which
Therapeutic Benefit Was Assesseda,b
Reference Citation(s)
|
Type of Study
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Type of Cancer
|
No. of Patients: Enrolled; Treated; Controlc
|
Strongest Benefit Reportedd
|
Concurrent Therapye
|
Level
of Evidence Scoref
|
[9,10] |
Phase I trial |
Advanced melanoma |
13;
13;
None |
Complete tumor response, 1
patient |
Yes |
3iiiDii |
[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 |
[8,12] |
Phase II trial |
Advanced renal cell |
208;
203;
Historical controls |
Improved disease-free survival |
Yes |
3iiiDi |
[5,7] |
Phase II trial |
Metastatic breast or ovarian |
22;
22;
None |
Complete/partial tumor response, 9 patients |
Yes |
3iiDiii |
No. = number.
|
aSee text for more details.
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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.
See text and glossary for definition of terms.
|
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
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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: 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]
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