Phase I Study of Intravenous Artesunate for Solid Tumors

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase One study to determine the safety, tolerability, and maximum tolerated dose of intravenous artesunate in patients with solid tumors. A rapid dose escalation design will be used, in which single patients will be enrolled to escalating dose levels until a grade 2 or higher toxicity occurs during cycle 1. Enrollment will then continue using 3 to 6 patients at each dose level until a dose is reached at which 2 or more patients out of 6 experience a treatment-related toxicity.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Georgetown University
• Collaborator: United States Department of Defense
• Treatments: Artemisinins; Artesunate

Criteria

Inclusion Criteria:

• At least one measurable lesion by RECIST criteria

• Willing to undergo pharmacogenetic testing

• Over the age of 18 years and able to provide informed consent

• No standard of care therapy available which has a proven overall survival benefit

• Adequate kidney, liver, and bone marrow function

• Life expectancy of greater than 3 months

• ECOG performance status less than or equal to 2

Exclusion Criteria:

• Chemotherapy or surgery within 4 weeks of treatment start

• Radiation treatment within 3 weeks prior to treatment start

• Untreated brain metastases or neurologically unstable CNS metastases

• Any severe or uncontrolled medical condition or other condition which could affect participation in the study including: unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarctionstudy entry

• Previous diagnosis of alpha- or beta-thalassemia

• Patients on a medication or herbal therapy known to inhibit CYP2A6, UGT1A9, or UGT2B7

• Female patients who are pregnant or breast feeding, or adult patients who are of reproductive potential and are unwilling to refrain from conceiving a child during study treatment

• Patients unwilling or unable to comply with the protocol, or provide informed consent