Clinical trial NCT02353026: Phase I Study of Intravenous Artesunate for Solid Tumors
Official title: A Phase I Study of Intravenous Artesunate in Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2015-02-02
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: A rapid dose escalation design will be used, in which single patients will be enrolled to each dose level until a grade \>/= 2 treatment-related toxicity occurs during cycle 1; enrollment then will proceed using a classic 3+ 3 dose escalation design. If the toxicity was grade 2, then enrollment will continue on that dose level. If the toxicity was grade 3 or 4, then enrollment will continue on one dose level below that dose. Dose escalation with the 3+3 design will continue until \>/= 2 patients out of 6 experience a treatment-related dose-limiting toxicity. Then, the maximum tolerated dose and recommended Phase II dose of intravenous artesunate will be one dose level below the level at which the toxicities occurred.

Eligibility 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 infarction \</= 6 months prior to study 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

Primary outcomes:
measure: Maximum Tolerated Dose
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown Lombardi Comprehensive Cancer Center
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: John F Deeken, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deeken JF, Wang H, Hartley M, Cheema AK, Smaglo B, Hwang JJ, He AR, Weiner LM, Marshall JL, Giaccone G, Liu S, Luecht J, Spiegel JY, Pishvaian MJ. A phase I study of intravenous artesunate in patients with advanced solid tumor malignancies. Cancer Chemother Pharmacol. 2018 Mar;81(3):587-596. doi: 10.1007/s00280-018-3533-8. Epub 2018 Feb 1.