The purpose of the research is to determine the highest dose of an oral compound called zeaxanthin that can be safely taken each day in patients with advanced cancer, the toxicity profile of zeaxanthin, and the dose of zeaxanthin to use in future cancer clinical trials.
Stage IV or unresectable stage 3 histologically confirmed solid tumor malignancy refractory to all standard therapies known to provide clinical benefit (unless the therapy is contraindicated or intolerable) in the opinion of the treating investigator for his/her tumor type. Subjects are not required to have received systemic therapies that have response rates under 20% with no associated survival benefit (for example DTIC chemotherapy and high dose Interleukin-2 in melanoma patients).
Age ≥ 18 years.
Performance status ECOG 0, 1 or 2
Absolute neutrophil count ≥ 1,500/mcL
Patients who have had chemotherapy or radiotherapy within 21 days prior to initiating study treatment or those who have not recovered to grade 1 or less from adverse events due to agents administered more than 21 days earlier excluding alopecia, gd 2 fatigue, gd 2 hearing loss from platinum agent, and endocrinopathies on stable replacement therapy.
Patients with active brain metastases requiring palliation with steroids and not stable for at least 4 weeks post radiation therapy or surgery.
Leptomeningeal carcinomatosis
History of allergic reactions attributed to compounds of similar chemical or biologic composition to zeaxanthin.
Parallel
Zeaxanthin
Biological/VaccineThe doses of zeaxanthin will be based on weight starting with 2 milligrams of zeaxanthin per kilogram of your body weight (mg/kg) followed by 4 mg/kg, 6 mg/kg, and finally 8 mg/kg. If a dose level is found to be unsafe, then a new group of patients will be treated at the midpoint dose between the not tolerated dose and the last tolerated dose. Zeaxanthin is supplied as 50 milligram capsules and a person's dose will be rounded to the nearest 50 milligrams.
Zeaxanthin Plus Pembrolizumab
Combination productThe doses of zeaxanthin will be based on weight starting with 2 milligrams of zeaxanthin per kilogram of your body weight (mg/kg) followed by 4 mg/kg, 6 mg/kg, and finally 8 mg/kg. If a dose level is found to be unsafe, then a new group of patients will be treated at the midpoint dose between the not tolerated dose and the last tolerated dose. Zeaxanthin is supplied as 50 milligram capsules and a person's dose will be rounded to the nearest 50 milligrams. The dose of pembrolizumab will be administered at a fixed dose of 400 milligrams intravenous every 6 weeks which is an FDA approved dosing schedule to treat cancer patients with pembrolizumab.
Zeaxanthin monotherapy
Recommended maximum tolerated dose Highest dose of zeaxanthin that does not cause dose limiting toxicity in patients with unresectable advanced solid tumors treated with zeaxanthin
Zeaxanthin monotherapy (continued)
Rate of Dose Limiting Toxicity (DLT) Based on CTEP Active Version (version 5.0) of the NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0) in patients with unresectable advanced solid tumors treated with zeaxanthin
Zeaxanthin plus Pembrolizumab
Recommended maximum tolerated dose Highest dose of zeoxanthin that does not cause dose limiting toxicity in patients with unresectable advanced solid tumors treated with zeaxanthin plus pembrolizumab
Zeaxanthin plus Pembrolizumab (continued)
Rate of Dose Limiting Toxicity (DLT) Based on CTEP Active Version (version 5.0) of the NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0) in patients with unresectable advanced solid tumors treated with zeaxanthin plus pembrolizumab
The response rate (ORR) of zeaxanthin in patients with unresectable advanced solid tumors
The ORR by RECIST v1.1 of zeaxanthin in patients with unresectable advanced solid tumors Duration of response: duration from date of initial attainment of CR or PR to date of progression, censoring at death or lost to follow-up Disease Control rate: percent of patients who develop CR, PR, or stable disease as best response as determined by RECIST v1.1 measured at 2 months and 6 months after initiation of study treatment Progression Free Survival: duration of time in months from the initiation of study treatment to date of progression, censoring at death or lost to follow-up.
The response rate of zeaxanthin plus pembrolizumab in patients with unresectable advanced solid tumors
The ORR by RECIST v1.1 of zeaxanthin plus pembrolizumab in patients with unresectable advanced solid tumors
The duration of response (DR) in patients with unresectable advanced solid tumors treated with zeaxanthin
The DR by RECIST v1.1 of zeaxanthin in patients with unresectable advanced solid tumors
The duration of response in patients with unresectable advanced solid tumors treated with zeaxanthin plus pembrolizumab
The DR by RECIST v1.1 of zeaxanthin plus pembrolizumab in patients with unresectable advanced solid tumors
On treatment biopsy for evidence of increased immune cell infiltration and vascularization to zeaxanthin in patients with unresectable advanced solid tumors treated with zeaxanthin
Measured by changes in immune cell populations and CD31 vascularization between baseline and on treatment tumor biopsy specimens
On treatment biopsy for evidence of increased immune cell infiltration and vascularization to zeoxanthin in patients with unresectable advanced solid tumors treated with zeaxanthin plus pembrolizumab
Measured by changes in immune cell populations and CD31 vascularization between baseline and on treatment tumor biopsy specimens
On treatment percentage changes in immune cell composition in peripheral blood in patients with unresectable advanced solid tumors treated with zeaxanthin
Measured by changes in the percentage of different immune cell populations between baseline and on treatment blood specimens
On treatment percentage changes in immune cell composition in peripheral blood in in patients with unresectable advanced solid tumors treated with zeaxanthin plus pembrolizumab
Measured by changes in percentage of different immune cell populations between baseline and on treatment blood specimens
Click on the lead sponsor to view all of their trials.
