Intralesional Chemotherapy for Laryngeal Cancer

DE
Overseen ByDavid E Rosow, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effects of injecting a chemotherapy drug directly into tumors for individuals with recurrent laryngeal cancer. The treatment combines cisplatin, a common chemotherapy drug, with epinephrine to enhance the drug's effects. Participants will receive three weekly doses before surgery. Candidates may qualify if their laryngeal cancer returned after radiation and they are prepared for chemotherapy injections and surgery. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to important findings.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be on any concurrent anticancer therapy. If you're taking steroids for allergies or other conditions, they are allowed if the dose is 10 mg/day or less.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that injecting a mix of cisplatin and epinephrine directly into tumors may help treat laryngeal cancer. In studies using this combination, about 25% of tumors responded, with some even shrinking completely, suggesting the treatment could be effective.

Regarding safety, past studies found that cisplatin and epinephrine are generally well-tolerated. Patients experienced some side effects, but these were mostly manageable. Since this trial is in the middle phase, early safety results have been promising enough to warrant further studies. This suggests that while risks exist, researchers believe they are acceptable compared to the potential benefits.

Prospective participants should discuss any concerns with the study team. They can provide more details on what to expect and how they will monitor safety during the trial.12345

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for laryngeal cancer, which often include radiation therapy or systemic chemotherapy, this new approach uses intralesional chemotherapy with a combination of cisplatin and epinephrine. This treatment is unique because it is delivered directly into the tumor, potentially increasing drug concentration at the cancer site while minimizing side effects to the rest of the body. Researchers are excited about this method as it may enhance the effectiveness of chemotherapy and reduce the need for more invasive procedures. By combining cisplatin with epinephrine, the treatment could improve drug absorption and retention within the tumor, offering a novel way to tackle laryngeal cancer.

What evidence suggests that this treatment might be an effective treatment for laryngeal cancer?

Participants in this trial will receive a combination of cisplatin and epinephrine injected directly into tumors. Research has shown that this combination can shrink tumors and improve symptoms. One study found that this mix effectively reduced tumor size, offering hope for treating laryngeal cancer. While cisplatin is a common cancer drug, adding epinephrine helps it remain longer at the tumor site, potentially enhancing its effectiveness. This approach has shown positive results in patients, suggesting it could be a viable option for those with recurring laryngeal cancer.26789

Who Is on the Research Team?

DR

David Rosow, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults over 18 with recurrent laryngeal squamous cell carcinoma who've had radiation treatment. They must be able to undergo weekly chemotherapy injections and surgery, not be pregnant or breastfeeding, have good organ function, and no major health issues that could affect their participation.

Inclusion Criteria

I have had radiation therapy for laryngeal cancer.
I am willing to have 3 weekly treatments under local anesthesia before surgery.
Willingness to avoid pregnancy based on specified criteria
See 3 more

Exclusion Criteria

Significant concurrent, uncontrolled medical condition
I am unable to make my own medical decisions.
Inability to tolerate awake, unsedated laryngeal procedures
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one dose of intralesional chemotherapy treatment per week over a period of approximately 3 weeks

3 weeks
3 visits (in-person)

Surgery

Participants undergo endoscopic surgery for their disease

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cisplatin
  • Epinephrine

Trial Overview

The study tests injecting a combination of Cisplatin (a chemotherapy drug) and Epinephrine directly into the tumor in the voice box. Participants will receive this treatment for three weeks before undergoing endoscopic surgery to assess its effectiveness.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Cisplatin + Epinephrine GroupExperimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39041364/

Effectiveness and feasibility of selective intra-arterial low ...

The m-RADPLAT regimen yielded favorable survival rates and clinical outcomes in patients with impaired renal function.

The Role of Intratumoral Therapy With Cisplatin ...

Cisplatin plus fluorouracil is one standard regimen for recurrent or metastatic HNSCC, with an overall response rate of 30%, a complete response rate of 5%, and ...

Synergistic Effects of Cisplatin-epigel and Interstitial KTP ...

This study examined the anticancer effects of interstitial laser treatment merge treatment using cisplatin-epigel and potassium titanyl phosphate (KTP)

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/12162764/

The Role of Intratumoral Therapy With cisplatin ...

Conclusion: Cisplatin/epinephrine injectable gel reduces tumor burden, ameliorates tumor symptoms, and provides a new therapeutic option for treating patients ...

The efficacy of cisplatin and low-temperature plasma ...

Conclusion Cisplatin injections combined with low-temperature plasma radiofrequency ablation has a significant effect on the treatment of locally advanced ...

Intralesional Chemotherapy (IC): Cisplatin + Epinephrine

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

A phase III placebo-controlled study in advanced head ... - PMC

With cisplatin/epinephrine gel, 25% (14 out of 57) of tumours responded (16% complete regression, 9% partial regression), vs 3% (one out of 35, complete ...

Cisplatin Plus Epinephrine in Treating Patients With ...

Combining more than one drug may kill more tumor cells. It is not yet known if treatment with cisplatin plus epinephrine is effective for head ...

Intralesional Chemotherapy (IC): Cisplatin + Epinephrine

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