Intralesional Chemotherapy (IC): Cisplatin + Epinephrine
ConditionLaryngeal Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami
About this trial
The purpose of this study is to determine the effects, good and bad, of injecting chemotherapy into recurrent laryngeal squamous cell carcinoma (SCC) tumors.
Eligibility criteria
Qualifiers
Men and women 18 years and older.
Previously treated for laryngeal SCC with radiation.
Must have biopsy-proven recurrent cancer requiring surgical management. Note: if participants do not have an archived tissue sample available for review, they may undergo a biopsy procedure for collection of a fresh tissue sample for diagnostic confirmation and determination of further treatment. In this case, a fresh tumor sample would be used for diagnostic confirmation and trial eligibility. Please note, this biopsy would be considered a standard of care (SOC) procedure since it is being performed for disease management purposes regardless of participant enrollment in the trial.
Participants must be willing to undergo 3 weekly cycles of IC under local anesthesia prior to surgery.
Disqualifiers
Inability to tolerate awake, unsedated laryngeal procedures. Participants may opt to receive pre-procedure diazepam.
Participant unable to receive contrast.
Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
< 10 weeks from completion of any radio- or toxin-immunoconjugates.
Trial design
Treatments tested in this trial
- Cisplatin
- Epinephrine injection
- Laryngeal Biopsy
- Endoscopic Surgery
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov