Determine Safety & Recommended Phase 2 Dosing of Zeaxanthin Alone or in Combination w/Pembrolizumab in Patients With Metastatic Cancer

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-99
SponsorValley Health System

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Zeaxanthin
  • Zeaxanthin Plus Pembrolizumab

Treatment groups

72 Participants
are divided into 2 treatment groups

Sponsors and collaborators