This study is currently on hold for participant recruitment at the James Graham Brown Cancer Center, located in Louisville, Kentucky.

Trial Description: A-dmDT390-bisFv(UCHT1) (Resimmune™) Fusion Protein in Combination With Ionizing Radiation for Treatment of Stage IV Melanoma

Resimmune or A-dmDT390-bisFv(UCHT1), an anti-T cell immunotoxin, is currently being studied as a treatment for cutaneous T cell lymphoma and other CD3+ malignant diseases (FDA IND Number: 100712, Scott and White Protocol 071163). During the course of this study, data accumulated that Resimmune could be acting as an immunomodulator. This was based on the observation that four out of six partial responses converted to complete responses at times ranging between 6 and 24 months following the completion of the single 4-day treatment protocol — and no other treatment took place (except in one patient who previously failed CHOP and received UVB for 6 months after leaving the immunotoxin study due to disease progression).

The purpose of this trial is to test the hypothesis that Resimmune can act as an immunomodulator of late stage metastatic melanoma when combined with palliative radiation to induce the priming of activated T cells with tumor antigens. The primary objective of this study is to determine the safety of combining Resimmune with palliative radiation therapy in patients with stage IV melanoma. A secondary objective is to document the tumor response and duration of response at irradiated and unirradiated sites (the abscopal effect). An additional secondary objective is to determine if T cell activation occurs following administration of Resimmune and local radiation to a metastatic lesion of melanoma.

There is growing evidence that high doses of radiation in the range of 10-20 Gy may increase the response rate of lesions outside of the radiation field suggesting induction of tumor-specific immunity (i.e. the abscopal effect) (Seung et al., 2012 a., b.). Immune-activating agents, including anti-CTLA-4 and IL-2, have been found to yield higher response rates against melanoma when combined with local radiation therapy of metastatic lesions (Postow et al., 2012 and Hinkler et al., 2012, Seung et al., 2012 a., b. and ClinicalTrials.gov NCT01449279). Although the precise mechanisms are not well understood, radiation may serve as an immune adjuvant by releasing melanoma antigens and causing infiltration of dendritic cells and T cells.

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Detailed study information at clinicaltrials.gov General Trial Information