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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Cisplatin

    Drug

    Participants will be administered 1 mg/mL Cisplatin via intralesional injection in combination with Epinephrine injection therapy. Total treatment volume will determined by the volume of the tumor to be injected.

  • Epinephrine injection

    Drug

    Participants will be administered a 1:50,000 dilution of epinephrine via intralesional injection in combination with cisplatin therapy. The total treatment volume will determined by the volume of the tumor to be injected.

  • Laryngeal Biopsy

    Procedure/Surgery

    At the time of the first intralesional chemotherapy (IC) dose, participants will have a biopsy of tumor tissue taken for standard of care (SOC) clinical activities. A portion of this sample will, if available, be banked for transcriptomic analysis.

  • Endoscopic Surgery

    Procedure/Surgery

    Participants with early disease will go on to have endoscopic surgical resection of their cancer while participants with advanced disease will receive a total laryngectomy, after completion of intralesional chemotherapy (IC) therapy. Resected tissue collected at the time of the surgical procedure (either cordectomy or total laryngectomy) will also be banked for correlative studies.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Cisplatin + Epinephrine GroupExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Overall Pathologic Response Rate (OPRR)

Overall Pathologic Response Rate (OPRR) is defined as the number of participants with a complete response (CR) or partial response (PR) as the best response to intralesional chemotherapy (IC) treatment. ORRR will be assessed by pathology as percentage viable tumor on histopathology at time of surgical resection.

Time frame
About six (6) weeks

Secondary outcomes

1

Number of Participants Experiencing Treatment-Related Serious Adverse Events (SAEs)

Incidence of treatment-related toxicity will be reported as the number of participants experiencing treatment-related serious adverse events (SAEs). SAEs will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, per physician discretion.

Time frame
About 18 weeks
2

Number of Participants Experiencing Treatment-Related Adverse Events (AEs)

Incidence of treatment-related toxicity will be reported as the number of participants experiencing treatment-related adverse events (AEs). AEs will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, per physician discretion.

Time frame
About 18 weeks
3

Overall Radiographic Response Rate (ORRR)

Overall Radiographic Response Rate (ORRR) is defined as the number of participants with a complete responses (CR) or partial response (PR) as the best response to intralesional chemotherapy (IC) treatment by radiography (percent regression on computed tomography (CT) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1, per physician discretion.

Time frame
About five (5) weeks
4

Overall Endoscopic Response Rate (OERR)

Overall Endoscopic Response Rate (OERR) is defined as the number of participants with a complete response (CR) or partial response (PR) as the best response to intralesional chemotherapy (IC) treatment by endoscopy (percent regression determined by blinded raters of pre- and post-IC endoscopy).

Time frame
About five (5) weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

Source ClinicalTrials.gov
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