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New treatment option for Laryngeal Squamous Cell Carcinoma
Official title Intralesional Chemotherapy (IC): Cisplatin + Epinephrine
ClinicalTrials.gov ID: NCT07392580
What this study is testing
What is Cisplatin?
Cisplatin is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for laryngeal squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to determine the effects, good and bad, of injecting chemotherapy into recurrent laryngeal squamous cell carcinoma (SCC) tumors.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- 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.
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN).
- Alanine transaminase (ALT)/aspartate aminotransferase (AST) ≤ 3.0 ULN.
- Calculated creatinine clearance ≥ 45 mL/min by the Cockcroft-Gault Equation or the estimated glomerular filtration rate ≥ 45 mL/min/1.73 m2 using the Modification of Diet in Renal Disease formula.
- Willingness to avoid pregnancy based on the criteria below:
- Woman of non-childbearing potential (ie, surgically sterile with a hysterectomy and/or bilateral oophorectomy OR ≥ 12 months of amenorrhea and at least 45 years of age).
- Woman of childbearing potential who has a negative urine or serum pregnancy test at screening and who agrees to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening and for at...
- 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.
- Steroids that are used for treatment of allergy or other underlying condition are permittable but not steroids started to treat cancer. Individuals receiving corticosteroids must be at a dose level ≤ 10 mg/day within 7...
- Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.
- Current or previous other malignancy within 3 years of trial entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or...
- Significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, gastrointestinal (GI), endocrine, pulmonary, neurological, cerebral, or psychiatric disease.
- Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment or exposure to a live vaccine within 30 days of dosing.
- Known human immunodeficiency virus (HIV) infection or positivity on immunoassay. Note: HIV screening test is optional.
- Current New York Heart Association Class II to IV congestive heart failure.
- Uncontrolled or symptomatic arrhythmia or stroke in last 6 months, liver cirrhosis, or autoimmune disorder requiring immunosuppression or long-term corticosteroids (\> 10 mg daily prednisone equivalent).
- Currently pregnant or breastfeeding.
- Any condition that would, in the Investigator's judgment, interfere with full participation in the trial, including administration of trial intervention and attending required trial visits; pose a significant risk to...
- Patients with impaired decision-making capacity.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.