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Table 3. Studies of NDV-Infected Tumor Cell Vaccines in Which Therapeutic Benefit Was Assesseda

Reference Citation(s)  Type of Study Type of Cancer No. of Patients: Enrolled; Treated; Controlb Strongest Benefit Reportedc Concurrent Therapyd Level of Evidence Scoree 
[32]Phase II/III (adjuvant setting)Melanoma29; 21; 8No advantage of vaccine for disease free survival or overall survivalNone1iA
[29]Phase III (adjuvant setting)Colorectal with liver metastases51; 25; 26Planned subgroup analysis, overall and disease free survival advantages in the colon of cancer patientsProtocol therapy was given after complete surgical resection of primary tumor and liver metastases1iiA
[31]Phase IIGlioblastoma35; 23; 87 (concurrent controls identified from within same hospital)Median progression-free survival of vaccinated patients was 40 wk (vs. 26 wk in controls; log-rank test, P = .024), median OS of vaccinated patients was 100 wk (vs. 49 wk in controls; log-rank test, P < .001)Protocol therapy after surgical debulking of tumor followed by radiation therapy2A
[15,22]Phase II trialMetastatic colorectal23; 23; Historical controlsImproved disease-free survivalNo3iiA
[23]Phase II trialOvarian82; 24h; NoneImproved disease-free survivalYes3iiDi
[16]Phase II trialAdvanced colorectal57; 48f; Historical controlsImproved overall survivalNo3iiiA
[17]Retrospective analysisEarly breast63; 63; Internal controlsgImproved overall survivalYes3iiiA
[21]Phase II trialMetastatic renal cell40; 40; Historical controlsImproved overall survival, 11 patients with complete/partial responsesYes3iiiA
[19]Phase II trialVarious advanced43; 31; NoneComplete tumor response, 1 patientYes3iiiDiii
[33]Phase IIGastrointestinal tumors, stage IV25; 25; 01 Complete response, 5 partial responses, overall response rate = 24%None described3iiiDiii
[33]Phase IIIColorectal567; 310; 257Higher mean and median survival for vaccination group compared to the resection group aloneNone describedNone describedi

No. = number; wk = week.
aRefer to text and the NCI Dictionary of Cancer Terms for additional information and definition of terms.
bNumber 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.
cThe strongest evidence reported that the treatment under study has anticancer activity or otherwise improves the well-being of cancer patients.
dChemotherapy, radiation therapy, hormonal therapy, or cytokine therapy given/allowed at the same time as vaccine therapy.
eFor information about levels of evidence analysis and an explanation of the level of evidence scores, refer to Levels of Evidence for Human Studies of Cancer Complementary and Alternative Medicine.
fOnly 48 patients were treated with NDV-infected tumor cell vaccines; the remaining patients were treated with another type of vaccine.
gThe patients were divided into groups that received a high-quality vaccine or a low-quality vaccine; the low-quality vaccine groups served as the controls; 32, 13, and 18 patients with early breast cancer, metastatic breast cancer, and metastatic ovarian cancer, respectively, received high-quality vaccines; the corresponding low-quality vaccine groups contained 31,14, and 13 patients.
hThere were 39 evaluable patients in this study, but findings were reported for only 24 patients.
iArticle does not provide enough information.

References

  1. Liebrich W, Schlag P, Manasterski M, et al.: In vitro and clinical characterisation of a Newcastle disease virus-modified autologous tumour cell vaccine for treatment of colorectal cancer patients. Eur J Cancer 27 (6): 703-10, 1991.  [PUBMED Abstract]

  2. Ockert D, Schirrmacher V, Beck N, et al.: Newcastle disease virus-infected intact autologous tumor cell vaccine for adjuvant active specific immunotherapy of resected colorectal carcinoma. Clin Cancer Res 2 (1): 21-8, 1996.  [PUBMED Abstract]

  3. Ahlert T, Sauerbrei W, Bastert G, et al.: Tumor-cell number and viability as quality and efficacy parameters of autologous virus-modified cancer vaccines in patients with breast or ovarian cancer. J Clin Oncol 15 (4): 1354-66, 1997.  [PUBMED Abstract]

  4. Bohle W, Schlag P, Liebrich W, et al.: Postoperative active specific immunization in colorectal cancer patients with virus-modified autologous tumor-cell vaccine. First clinical results with tumor-cell vaccines modified with live but avirulent Newcastle disease virus. Cancer 66 (7): 1517-23, 1990.  [PUBMED Abstract]

  5. Pomer S, Schirrmacher V, Thiele R, et al.: Tumor response and 4 year survival-data of patients with advanced renal-cell carcinoma treated with autologous tumor vaccine and subcutaneous R-IL-2 and IFN-alpha(2b). Int J Oncol 6 (5): 947-54, 1995.  [PUBMED Abstract]

  6. Schlag P, Manasterski M, Gerneth T, et al.: Active specific immunotherapy with Newcastle-disease-virus-modified autologous tumor cells following resection of liver metastases in colorectal cancer. First evaluation of clinical response of a phase II-trial. Cancer Immunol Immunother 35 (5): 325-30, 1992.  [PUBMED Abstract]

  7. Möbus V, Horn S, Stöck M, et al.: Tumor cell vaccination for gynecological tumors. Hybridoma 12 (5): 543-7, 1993.  [PUBMED Abstract]

  8. Schulze T, Kemmner W, Weitz J, et al.: Efficiency of adjuvant active specific immunization with Newcastle disease virus modified tumor cells in colorectal cancer patients following resection of liver metastases: results of a prospective randomized trial. Cancer Immunol Immunother 58 (1): 61-9, 2009.  [PUBMED Abstract]

  9. Steiner HH, Bonsanto MM, Beckhove P, et al.: Antitumor vaccination of patients with glioblastoma multiforme: a pilot study to assess feasibility, safety, and clinical benefit. J Clin Oncol 22 (21): 4272-81, 2004.  [PUBMED Abstract]

  10. Voit C, Kron M, Schwürzer-Voit M, et al.: Intradermal injection of Newcastle disease virus-modified autologous melanoma cell lysate and interleukin-2 for adjuvant treatment of melanoma patients with resectable stage III disease. J Dtsch Dermatol Ges 1 (2): 120-5, 2003.  [PUBMED Abstract]

  11. Liang W, Wang H, Sun TM, et al.: Application of autologous tumor cell vaccine and NDV vaccine in treatment of tumors of digestive tract. World J Gastroenterol 9 (3): 495-8, 2003.  [PUBMED Abstract]