Trial Radar KI | ||
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Die klinische Studie NCT07495098 für Metastasierter Lungenkrebs, Lung Cancer (NSCLC) ist noch nicht rekrutierend. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
University of VermontPhase 1B Trial of Intratumoral Cisplatin for Stage IV Lung Cancer Phase 1 12 Immuntherapie
Non-small cell lung cancer (NSCLC) is the leading cause of cancer-related death in the United States. The mainstay of therapy for lung cancer remains platinum-based chemotherapy. One of the most commonly used agents is cisplatin, due to the fact that it is highly toxic to cancer cells. Cisplatin binds with DNA, cross-linking strands and thereby inhibiting mitosis, which in turn leads to apoptosis and deat...
Mehr anzeigenPhase 1B Trial of Intratumoral Cisplatin for Stage IV Lung Cancer
- 00000613B
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellInitial Dose Cohort: 95% Tumor Coverage Intratumoral cisplatin dosed to cover 95% of the tumor | cisplatin (cis-diamminedichloroplatinum(II) (CDDP)) The safety of intratumoral cisplatin will be evaluated by delivery region will be evaluated. |
ExperimentellDe-escalation Dose Cohort: 90% Tumor Coverage Intratumoral cisplatin dosed to cover 90% of the tumor | cisplatin (cis-diamminedichloroplatinum(II) (CDDP)) The safety of intratumoral cisplatin will be evaluated by delivery region will be evaluated. |
ExperimentellEscalation Dose Cohort: 98% Tumor Coverage Intratumoral cisplatin dosed to cover 98% of the tumor | cisplatin (cis-diamminedichloroplatinum(II) (CDDP)) The safety of intratumoral cisplatin will be evaluated by delivery region will be evaluated. |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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. | For 4 weeks after initial delivery of intratumoral cisplatin |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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) | At each delivery |
Age 18 years or above
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.
A CT scan of the chest (with or without contrast) within the prior 3 months.
The presence of an EBUS accessible target site determined by a treating investigator. These may be primary lung cancers or metastatic sites (including when a lymph node station has been replaced by metastatic tumor), that are accessible by EBUS.
MDC agreement of likely Stage IV NSCLC (confirmation from at minimum a Medical Oncologist and Radiation Oncologist on clinical stage).
Patients must have adequate organ and marrow function as defined below:
- Leukocytes ≥3,000/mcL
- Platelets ≥100,000/mcL
- Total bilirubin ≤ institutional upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤ institutional ULN
- Creatinine ≤ institutional ULN
- 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
- Allergy to iodinated contrast
- Patient not appropriate for the research study based on physician discretion
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