Methods of Identifying Effective Off-Guideline Treatments for Advanced Cancer Patients
ConditionAdvanced Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCancer Commons
About this trial
Many FDA-approved drugs are not available to patients with a particular cancer because there has been no successful clinical trial conducted for that drug against that cancer. In the absence of such a successful clinical trial, the drug is not included in the National Comprehensive Cancer Network (NCCN) guidelines list of approved drugs for that cancer. The absence of a drug in the NCCN Guidelines for a particular cancer is usually not an indication that the drug has been shown to be ineffective for patients with that cancer. Rather, it is an indication that there is insufficient clinical trial evidence to include it. A drug that is FDA-approved for one or more cancers but is not in the NCCN Guidelines for a particular cancer is called an "off-guideline" drug for that cancer.
This study is being done to measure and compare the reliability of multiple different treatment selection tests to predict a participant's response to an off- guideline cancer therapy. The results can guide oncologists to effective off-guideline drugs that would otherwise not be available to their advanced cancer patients. As this is an observational study, all the data gathered and analyzed will be generated in the normal practice of medicine, not by the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant must have a valid genomic or functional test or willing to undergo a new test
Analysis of the participant's test must produce a set of Promising Off-guideline Drug(s)
Oncologist must be willing to administer one or more Promising Off-guideline Drug(s)
The study team must have an approved method of paying for the administered Off-Guideline Drug(s). Health insurance and self-pay are the two most common sources of payment
Disqualifiers
No set of Promising Off-guideline Drug(s)
Oncologist not willing to administer one or more Promising Off-guideline Drug(s)
No approved method of paying for the administered off-guideline Drug(s)
No signed Informed Consent
Trial population
The study will include advanced cancer patients who have test result that can be used by the Scientific Team to identify Promising Off-guideline Drugs. The study is open to patients with any cancer.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
The predictive accuracy for each drug sensitivity testing (DST) used in the study
For each participant in the study who is treated with an off-guideline drug, the oncologist will provide the study with a binary assessment of "response" or "no response" from the participant, using the RECIST criteria or other criteria proposed by the treating oncologist. For each participant, we will compare the test prediction of "response" or "no response" to the oncologist assessment of "response" and "no response" to determine if the test prediction was correct or incorrect. For each test, we will compute the predictive accuracy of the test by dividing the number of correct predictions by dividing the number of correct predictions by the total number of predictions made by the test in the course of the study. For example, if a test made fifty (50) predictions and thirty five (35) of those predictions were correct, then the predictive accuracy of the test would be 35/50 = 70%.
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
The overall patient response rate for each DST-guided therapy and for each cancer.
To compare individual outcomes (response and disease-free survival) in patients treated with DST-guided therapy as compared to non-DST guided (conventional) therapy.
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov