Melanoma Clinical Trial
Official title:
Phase I/II Trial of A-dmDT390-bisFv(UCHT1) Fusion Protein in Combination With Ionizing Radiation for the Treatment of Stage IV Melanoma
The purpose of this trial is to study A-dmDT390-bisFv(UCHT1) in combination with ionizing irradiation for the treatment of stage IV melanoma, a disease that is essentially incurable with median overall survival periods that range from 8-16 months.
A-dmDT390-bisFv(UCHT1) (Resimmune™), 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 4-day treatment protocol and
no other treatment took place.
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 A-dmDT390-bisFv(UCHT1) and local radiation to a metastatic lesion of
melanoma.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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