drugset / Trial / NCT00623766
Evaluation of Tumor Response to Ipilimumab in the Treatment of Melanoma With Brain Metastases
Non-randomizedSingle-groupOpen-labelTreatment
Summary
To assess the response of melanoma with brain metastases to ipilimumab treatment while maintaining acceptable tolerability.
Timeline
- Start
- 2008-07
- Primary completion
- 2009-09
- Completion
- 2012-10
Publications
- Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.
- Johnson DB, Friedman DL, Berry E, Decker I, Ye F, Zhao S, Morgans AK, Puzanov I, Sosman JA, Lovly CM. Survivorship in Immune Therapy: Assessing Chronic Immune Toxicities, Health Outcomes, and Functional Status among Long-term Ipilimumab Survivors at a Single Referral Center. Cancer Immunol Res. 2015 May;3(5):464-9. doi: 10.1158/2326-6066.CIR-14-0217. Epub 2015 Feb 3.
- Iwama S, De Remigis A, Callahan MK, Slovin SF, Wolchok JD, Caturegli P. Pituitary expression of CTLA-4 mediates hypophysitis secondary to administration of CTLA-4 blocking antibody. Sci Transl Med. 2014 Apr 2;6(230):230ra45. doi: 10.1126/scitranslmed.3008002.
- Margolin K, Ernstoff MS, Hamid O, Lawrence D, McDermott D, Puzanov I, Wolchok JD, Clark JI, Sznol M, Logan TF, Richards J, Michener T, Balogh A, Heller KN, Hodi FS. Ipilimumab in patients with melanoma and brain metastases: an open-label, phase 2 trial. Lancet Oncol. 2012 May;13(5):459-65. doi: 10.1016/S1470-2045(12)70090-6. Epub 2012 Mar 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Background | Betamethasone | Other / unclassified | — | — |
| Background | Dexamethasone | Small molecule | — | — |
| Background | Fludrocortisone | Other / unclassified | — | — |
| Background | Hydrocortisone | Other / unclassified | — | — |
| Background | Meprednisone | Other / unclassified | — | — |
| Background | Methylprednisolone | Other / unclassified | — | — |
| Background | Prednisolone | Other / unclassified | — | — |
| Background | Prednisone | Other / unclassified | — | — |
| Background | Triamcinolone | Other / unclassified | — | — |