A-dmDT390-bisFv(UCHT1) Fusion Protein in Combination With Ionizing Radiation for Treatment of Stage IV Melanoma
Drug: A-dmDT390-bisFv(UCHT1) (Resimmune®)
Radiation: Ionizing Radiation
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Immune-related overall response rate (irORR) [ Time Frame: For up to 1 year post treatment or until disease progression ] [ Designated as safety issue: Yes ]Response will be assessed at 2 months, and at least every 3 months (±7 days) thereafter using for up to 1 year after the last treatment administration or until evidence of disease progression. Tumor measurements and therapeutic response will be determined using irRC (Immune Related Response Criteria). At a minimum, CT scans of the chest, abdomen, and pelvis will be performed at study entry, at 2 months, and, if a response or stable disease, at least every 3 months (±7 days) for up to 1 year after the last dose of study drug, and/or at any time there is clinical evidence of disease progression, to evaluate disease status.
- Overall survival [ Time Frame: every 3 months for up to 3 years ] [ Designated as safety issue: Yes ]Survival should be assessed and a physical exam should be completed every three months as per standard of care
- Treatment Duration [ Time Frame: 4 Days ] [ Designated as safety issue: Yes ]Patients will be admitted to the hospital on day 0 for the first two infusions on day 1. Infusions for days 2, 3 and 4 and fractionated radiation will be done in the clinic on an outpatient basis.
|Study Start Date:||February 2014|
|Estimated Primary Completion Date:||December 2020 (Final data collection date for primary outcome measure)|
Experimental: A-dmDT390-bisFv(UCHT1) with Ionizing Radiation
A-dmDT390-bisFv(UCHT1) Fusion Protein in Combination With Ionizing Radiation
|Drug: A-dmDT390-bisFv(UCHT1) (Resimmune®) Radiation: Ionizing Radiation|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01888081
|United States, Kentucky|
|James Graham Brown Cancer Center|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Jason Chesney, MD, PhD||James Graham Brown Cancer Center, University of Louisville|