Phase 1B Trial of Intratumoral Cisplatin for Stage IV Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Vermont
About this trial
The addition of intravenous (given through a vein) cisplatin to immunotherapy improves treatment outcomes for lung cancer, but unfortunately results in significantly more side effects since the rest of the body is exposed to significant amounts of the drug. Our clinical trial data indicate that injecting cisplatin directly into the tumor using a bronchoscope (a small flexible tube with a camera in it) has very few side effects, and results in significant cell death and potentially improvement in the immune response. The goal of this proposal is to evaluate a computational approach, that incorporates data from a CT scan, to determine the optimal dose and delivery location within a tumor to maximize tumor cell killing and the immune response.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Eastern Cooperative Oncology Group (ECOG) performance score 0-2
Have known or suspected metastatic NSCLC at time of enrollment (including patients who progress on initial therapy or are found to have metastatic disease during therapy and are not excluded
Patient is able and willing to provide informed consent.
Rapid on-site cytopathologic examination (ROSE) performed during the procedure (if not previously diagnosed) and returns likely NSCLC. No injection will be performed if ROSE is non-diagnostic.
Disqualifiers
Use of an investigational agent in prior 30 days
Pregnancy/lactation (pregnancy test to be performed by pre-op as part of standard of care for women of child-bearing age as defined by UVMMC Policy NPREP16)
Treatment with intravenous cytotoxic chemotherapy within the past 14 days
Allergy to cisplatin or its derivatives
Trial design
Design model
Single group
Treatments tested in this trial
cisplatin (cis-diamminedichloroplatinum(II) (CDDP))
DrugThe safety of intratumoral cisplatin will be evaluated by delivery region will be evaluated.
Treatment groups
12 Participants
are divided into 3 treatment groupsGroup A: Initial Dose Cohort: 95% Tumor CoverageExperimental treatment 1 intervention
Group B: De-escalation Dose Cohort: 90% Tumor CoverageExperimental treatment 1 intervention
Group C: Escalation Dose Cohort: 98% Tumor CoverageExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety, as defined by dose limiting toxicity (DLT)
Safety (dose limiting toxicity, DLT), as defined by CTCAE (Common Terminology Criteria for Adverse Events) v 6.0. CTCAE grade 3 or above will be considered a DLT.
Time frame
For 4 weeks after initial delivery of intratumoral cisplatinSecondary outcomes
1
Cisplatin retention
Post-injection platinum blood levels will allow calculation of retained cisplatin mass via an established pharmacokinetic model. Cisplatin retention will be evaluated by location of injection (low vs high % blood volume)
Time frame
At each deliveryOther outcomes
1
Changes in the tumor microenvironment by dose
Biopsies will be evaluated for cell death and changes in the tumor microenvironment. Specifically CD8+/CD4+, total CD8, and T cell receptor epitope variability
Time frame
At 1 week after each delviery of intratumoral cisplatin, by delivery regionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: