Not Yet RecruitingPhase 2

Intralesional Chemotherapy (IC): Cisplatin + Epinephrine

United States20 participantsStarted 2026-04-01

Plain-language summary

The purpose of this study is to determine the effects, good and bad, of injecting chemotherapy into recurrent laryngeal squamous cell carcinoma (SCC) tumors.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.
✓. Adequate hematologic, hepatic, and renal function tested within 6 weeks prior to the start of therapy (values must not be achieved with growth factors):
✓. Absolute neutrophil count (ANC) ≥ 1.0 × 10\^9 cells /L.
✓. Hemoglobin ≥ 8.0 g/dL.
✓. Platelet count ≥ 50 × 10\^9 platelets/L.

Exclusion criteria

✕. 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).
✕. Receipt of anticancer medications or investigational drugs within the following intervals before the date of the first dose of trial intervention:
✕. \< 10 weeks from completion of any radio- or toxin-immunoconjugates.
✕. \< 4 weeks for immunotherapy.
✕. \< 3 weeks for radiotherapy.
✕. \< 2 weeks for any investigational agent or other anticancer medications.

What they're measuring

Overall Pathologic Response Rate (OPRR)

Timeframe: About six (6) weeks

Trial details

NCT IDNCT07392580

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-04-01

Contact for this trial

David E Rosow, MD

+1 (305) 2432587 DRosow@med.miami.edu

View on ClinicalTrials.gov More Laryngeal Squamous Cell Carcinoma trials