New injection shrinks throat tumors before surgery?
NCT ID NCT07392580
First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times
Summary
This study tests injecting the chemotherapy drug cisplatin directly into throat cancer tumors that have come back after radiation. About 20 adults will receive the injection before planned surgery to remove the tumor. Researchers will check how many tumors shrink or disappear and track any side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Men and women 18 years and older. 2. Previously treated for laryngeal SCC with radiation. 3. 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. 4. Participants must be willing to undergo 3 weekly cycles of IC under local anesthesia prior to surgery. 5. Adequate hematologic, hepatic, and renal function tested within 6 weeks prior to the start of therapy (values must not be achieved with growth factors): 1. Absolute neutrophil count (ANC) ≥ 1.0 × 10\^9 cells /L. 2. Hemoglobin ≥ 8.0 g/dL. 3. Platelet count ≥ 50 × 10\^9 platelets/L. 4. Total bilirubin ≤ 1.5 × upper limit of normal (ULN). 5. Alanine transaminase (ALT)/aspartate aminotransferase (AST) ≤ 3.0 ULN. 6. 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. 6. Willingness to avoid pregnancy based on the criteria below: 1. 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). 2. 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 least 14 months after the last dose of trial intervention. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participant and their understanding confirmed. Exclusion Criteria: 1. Inability to tolerate awake, unsedated laryngeal procedures. Participants may opt to receive pre-procedure diazepam. 2. Participant unable to receive contrast. 3. Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization). 4. Receipt of anticancer medications or investigational drugs within the following intervals before the date of the first dose of trial intervention: 1. \< 10 weeks from completion of any radio- or toxin-immunoconjugates. 2. \< 4 weeks for immunotherapy. 3. \< 3 weeks for radiotherapy. 4. \< 2 weeks for any investigational agent or other anticancer medications. 5. 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 days of the trial intervention administration. 5. Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy. 6. 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 other noninvasive or indolent malignancy. 7. Significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, gastrointestinal (GI), endocrine, pulmonary, neurological, cerebral, or psychiatric disease. 8. Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment or exposure to a live vaccine within 30 days of dosing. 9. Known human immunodeficiency virus (HIV) infection or positivity on immunoassay. Note: HIV screening test is optional. 10. Current New York Heart Association Class II to IV congestive heart failure. 11. 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). 12. Currently pregnant or breastfeeding. 13. 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 the patient; or interfere with interpretation of trial data. 14. Patients with impaired decision-making capacity.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Miami
RECRUITINGMiami, Florida, 33136, United States
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Other studies related to the condition(s) this trial covers.
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