Individualized Treatments in Adults With Relapsed/Refractory Cancers
Overview
- Phase
- Not Applicable
- Intervention
- Drug Sensitivity Test (DST)
- Conditions
- Refractory Cancer
- Sponsor
- Case Comprehensive Cancer Center
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Treatment recommendation feasibility
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
A personalized cancer medicine approach would address therapy resistance, cancer metastasis, and limited options after standard of care is exhausted in advanced cancer participants. This approach may reduce the barriers to approved therapeutic assignment currently limited to a particular cancer type or patient demographic.
Detailed Description
Treatment itself will not be given as part of this trial. The results of the drug sensitivity test (DST) and genomic screening will be used to inform treating physician about participant-specific drug sensitivity or resistance guiding best therapy choices. The physician will decide the most appropriate treatment for each case, with the option to add one or more personalized (assay-guided) drug(s) from the investigational platform. All participants will need to be consented separately for any subsequent investigational treatment if no standard treatment options are available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants aged 18 years or older at the time of enrollment on this study of any gender, race, or ethnicity.
- •Patients with suspected or confirmed diagnosis of recurrent or refractory cancer with no curative treatment options.
- •Participants who have undergone at least two lines of previous therapy.
- •Participants who are scheduled for or have recently had biopsy or tumor excised (solid tumors) or bone marrow aspirate (blood cancers) or who have scheduled or recently had paracentesis or thoracentesis performed.
- •Participants willing to have a blood draw or buccal swab done for the purposes of genetic testing.
- •Participants willing to sign informed consent.
Exclusion Criteria
- •Participants who do not have malignant tissue available and accessible.
- •Participants for whom the amount of excised malignant tissue is not sufficient for the ex vivo drug testing and/or genetic profiling.
- •Participants with newly diagnosed tumors and tumors that have high (\>90%) cure rate with safe standard therapy.
Arms & Interventions
Drug Sensitivity Testing
The results of the DST and genomic screening will be used to inform treating physician about participant-specific drug sensitivity or resistance guiding best therapy choices. The physician will decide which treatment will be most appropriate for each case. All participants will need to be consented separately for any subsequent investigational treatment if no standard treatment options are available.
Intervention: Drug Sensitivity Test (DST)
Outcomes
Primary Outcomes
Treatment recommendation feasibility
Time Frame: Up to 4 weeks post-treatment
Primary objective is to determine feasibility of providing treatment recommendations to relapsed and refractory adult cancer patients based on ex vivo drug sensitivity testing (DST). Feasibility will be demonstrated if it is possible to recommend treatment within 4 weeks in at least 22 of 36 participants (62.5%).
Secondary Outcomes
- Treatment responsiveness(Up tp 1 year post-treatment)
- Progression-free survival(Up tp 1 year post-treatment)
- Progression-free survival ratio(Up to 1 year post-treatment)