Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments

Recruiting

• Conditions: Stage IV Non-small Cell Lung Cancer; Stage IV Malignant Melanoma; Stage IV Small Cell Lung Cancer; Stage III Malignant Melanoma

• Registration Number: NCT04056247
• Lead Sponsor: OncoHost Ltd.

Brief Summary

This study will develop an algorithm of identifying patients with stage IV NSCLC and Melanoma who could benefit from cancer treatment they receive.

Detailed Description

The goal of this research study is to develop an algorithm that predicts the patient's treatment outcome.This algorithm will serve as a tool for physicians when making treatment decisions, specifically for stage IV NSCLC and malignant melanoma patients receiving anti-cancer treatments. The investigators also aim to identify the metabolic pathways that could lead to better therapeutic options. The patients will be given their treatment according to the institute's standard of care. The patients will provide two blood samples and clinical data will be collected from their medical records.

In the first part of the trial, the data obtained from the blood samples and the medical records of the patients will be used to develop the prediction algorithm, and in the second part of the trial, the algorithm will be validated by comparing the objective response rate of the patients to the theoretical response prediction of the algorithm.

Study Timeline

• Study First Submitted: 2019-08-11
• Study First Submitted QC: 2019-08-13
• Study First Posted: 2019-08-14
• Study Start: 2019-10-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-25
• Last Update Posted: 2023-08-29
• Primary Completion: 2029-10-01
• Study Completion: 2029-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Cancer patients with stage IV NSCLC or stage IV malignant melanoma

• Patient must have at least one measurable lesion and the relevant images in order to enable assessment of response

• ECOG PS - 0/1-2

• Normal hematologic, renal and liver function:

  1. Absolute neutrophil count higher than 1500/mm3
  2. Platelets count higher than 100,000/mm3
  3. haemoglobin higher than 9 g/dL
  4. Creatinine concentration ≤1.4 mg/dL, or creatinine clearance higher than 40 mL/min
  5. Total bilirubin lower than 1.5 mg/dL, ALT and AST levels ≤ 3 times above the upper normal limit.

Exclusion Criteria

• Concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug
• Generalized impairment or mental incompetence that would render the patient unable to understand his/her participation in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR) at 3 months	At 3 months after therapy	ORR as defined by RECIST 1.1 or other validated method for ORR evaluation
Overall response rate (ORR) at 6 months	At 6 months after therapy	ORR as defined by RECIST 1.1 or other validated method for ORR evaluation
Changes in the blood levels of different proteins that represent the host response	At baseline (pre-therapy) and after 1st dose administration (post therapy)	Changes in Blood levels of proteins representing the Host response

Trial Locations

Locations (41)

Birmingham VAHCS; 🇺🇸 Birmingham, Alabama, United States

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Florida Cancer Specialist and Research Institute; 🇺🇸 Orlando, Florida, United States

Protean Biodiagnosics; 🇺🇸 Orlando, Florida, United States

Northwest Community Healthcare; 🇺🇸 Rolling Meadows, Illinois, United States

Helen Nassif Community Cancer Center; 🇺🇸 Cedar Rapids, Iowa, United States

Rutgers Cancer Institute; 🇺🇸 New Brunswick, New Jersey, United States

Roswell Park; 🇺🇸 Buffalo, New York, United States

West Clinic; 🇺🇸 Germantown, Tennessee, United States

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