At a glance
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A Phase I Trial of Weekly Indenoisoquinoline LMP400 in Adults With Relapsed Solid Tumors and Lymphomas
In Brief
A Phase 1 clinical trial evaluating LMP400 for Neoplasm and Lymphoma. Completed, enrolled 21 participants across 1 site.
Detailed Summary
Background: \- Indenoisoquinoline LMP400 is an experimental cancer treatment drug. It damages DNA in tumor cells. Tumor cells with damaged DNA may die, resulting in cell death. Researchers want to see if this drug is a safe and effective treatment for solid tumors and lymphomas that have not responded to earlier treatment. Objectives: \- To see if Indenoisoquinoline LMP400 is a safe and effective treatment for advanced solid tumors or lymphomas. Eligibility: \- Individuals at least 18 years of age who have solid tumors or lymphomas that have not responded to treatment. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Tumor samples may also be collected. The size and location of the tumors will be determined with imaging studies. * Indenoisoquinoline LMP400 is given in a 28-day cycle. Participants will receive the drug by intravenous infusion on days 1, 8, and 15 of each cycle, followed by a break of 13 days without the drug. * Treatment will be monitored with frequent blood tests and imaging studies. Tumor samples will be optional. * Participants will continue their cycles of treatment as long as the cancer does not grow and there are no severe side effects.
Study Details
Timeline
Interventions
Top1 inhibitors such as LMP400 are potent anticancer agents because stabilizing cleavage complex formation induces replication-and transcription-mediated DNA damage and delays DNA repair, leading to apoptosis. Preclinical and clinical data indicate that baseline tumor levels of Top1 correlate strongly with ability to respond to Top1 inhibitor therapy.