Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments
Purpose
This study will develop an algorithm of identifying patients with stage IV NSCLC and Melanoma who could benefit from cancer treatment they receive.
Conditions
- Stage IV Non-small Cell Lung Cancer
- Stage IV Malignant Melanoma
- Stage IV Small Cell Lung Cancer
- Stage III Malignant Melanoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Newly diagnosed NSCLC stage IV | Patients with newly diagnosed stage IV NSCLC treated with Immunotherapy or Immunotherapy + Chemotherapy. |
|
| NSCLC stage IV 2nd line and further of immunotherapy | Patients with NSCLC stage IV treated with Immunotherapy at 2nd line or consecutive lines. |
|
| Malignant melanoma stage IV | Patients with stage IV malignant melanoma treated with Immunotherapy with or without targeted therapy. |
|
| Malignant melanoma stage IIIb-d | Patients with stage IIIb-d malignant melanoma treated with Immunotherapy as adjuvant therapy. |
|
| SCLC stage IV | Patients with stage IV SCLC treated with Immunotherapy or Immunotherapy + Chemotherapy. |
|
Recruiting Locations
Orlando, Florida 32827
Orlando, Florida 32827
Anthony Magliocco, MD
Rolling Meadows, Illinois 60008
Cedar Rapids, Iowa 52403
New Brunswick, New Jersey 08903
Houston, Texas 77030
More Details
- NCT ID
- NCT04056247
- Status
- Recruiting
- Sponsor
- OncoHost Ltd.
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.