drugset / Trial / NCT00518206
Study of NY-ESO-1 ISCOMATRIX® in Patients With Measurable Stage III or IV Melanoma
Phase 2
Completed
46 enrolled
Ludwig Institute for Cancer Research
Austin Health · collabPeter MacCallum Cancer Institute · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This was a Phase 2, open-label study of the NY-ESO-1 ISCOMATRIX® (ISCOM) vaccine administered as an intramuscular injection given every 4 weeks to subjects with measurable advanced malignant melanoma. Study objectives included determination of the anticancer activity, cellular and humoral immunogenicity, and safety and tolerability of the NY-ESO-1 ISCOM vaccine administered alone or preceded by a single administration of low-dose cyclophosphamide.
Timeline
- Start
- 2003-11-28
- Primary completion
- 2010-01-22
- Completion
- 2010-01-22
Publications
- Results Nicholaou T, Ebert LM, Davis ID, McArthur GA, Jackson H, Dimopoulos N, Tan B, Maraskovsky E, Miloradovic L, Hopkins W, Pan L, Venhaus R, Hoffman EW, Chen W, Cebon J. Regulatory T-cell-mediated attenuation of T-cell responses to the NY-ESO-1 ISCOMATRIX vaccine in patients with advanced malignant melanoma. Clin Cancer Res. 2009 Mar 15;15(6):2166-73. doi: 10.1158/1078-0432.CCR-08-2484. Epub 2009 Mar 10.
- Results Klein O, Davis ID, McArthur GA, Chen L, Haydon A, Parente P, Dimopoulos N, Jackson H, Xiao K, Maraskovsky E, Hopkins W, Stan R, Chen W, Cebon J. Low-dose cyclophosphamide enhances antigen-specific CD4(+) T cell responses to NY-ESO-1/ISCOMATRIX vaccine in patients with advanced melanoma. Cancer Immunol Immunother. 2015 Apr;64(4):507-18. doi: 10.1007/s00262-015-1656-x. Epub 2015 Feb 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 300 mg/m2 | Intravenous |
| Subject | NY-ESO-1 ISCOMATRIX® vaccine | Vaccine | 100 ug | Intramuscular |
| Subject | NY-ESO-1 ISCOMATRIX® vaccine | Vaccine | 120 ug | Intramuscular |