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Alkylating agents

Cisplatin + Epinephrine for Head and Neck Cancer

Phase 3

Waitlist Available

Research Sponsored by Matrix Pharmaceutical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No uncontrolled local infection at treatment sites

Performance status: Karnofsky 60%-100%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying how well cisplatin and epinephrine work when given together as an injection into the tumor in patients with head and neck cancer that has returned or does not respond to treatment.

Who is the study for?

This trial is for adults with recurrent or refractory squamous cell carcinoma of the head and neck, who have already tried at least one therapy. Eligible tumors must be accessible for injection without risk of severe bleeding, not exceed 20 cc in volume, and not involve major arteries or organs. Patients should have a life expectancy of at least 6 months and be able to consent.Check my eligibility

What is being tested?

The effectiveness of cisplatin combined with epinephrine in an injectable gel form is being tested against head and neck cancer that has come back or hasn't responded to treatment. This phase III trial randomly assigns patients to receive either this combination treatment or a control under double-blind conditions.See study design

What are the potential side effects?

Potential side effects may include allergic reactions due to ingredients like bovine collagen or sulfites in the gel, as well as typical chemotherapy-related issues such as fatigue, nausea, blood disorders (low platelet count), kidney function changes, and possible cardiovascular complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have an untreated infection at the site where I will receive treatment.

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I can care for myself but may not be able to do active work.

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My kidney function, measured by creatinine, is within normal limits.

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I have no major history of neck artery disease from plaque buildup, radiation, or surgery.

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My head or neck cancer has come back or didn't respond after treatment.

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I don't have scar tissue from previous radiation without cancer growth.

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My cancer can be directly injected without causing bleeding or blockage.

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My cancer has not spread to or is threatening major blood vessels.

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I am 18 years old or older.

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I do not have severe heart problems.

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I don't have a heart rhythm problem that could make treatment risky.

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My largest tumor is between 0.5 and 20 cc in size.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Matrix PharmaceuticalLead Sponsor

2 Previous Clinical Trials

55 Total Patients Enrolled

Mack H. Mabry, MDStudy ChairSUGEN

1 Previous Clinical Trials

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00002659 — Phase 3

Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00002659 — Phase 3

Head and Neck Cancers Research Study Groups:

Head and Neck Cancers Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT00002659 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any patients still needed for this research study?

"Unfortunately, this study is no longer recruiting patients. The last update to the posting on clinicaltrials.gov was on December 18th, 2013. Even though this particular study is not taking candidates, there are 498 other trials that are."

Answered by AI

Could you please summarize the risks and side effects of this treatment?

"Since this is a Phase 3 trial, there is already some clinical evidence of this treatment's efficacy and multiple rounds of data supporting safety, so we gave it a score of 3."

Answered by AI

In how many distinct locations is this research project currently active?

"Right now, potential patients can go to 28 different locations to enroll in this trial. Some of these locations are in Miami, San Francisco and Atlantis. If you enroll, try and choose a site close to you to limit travel."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cisplatin Plus Epinephrine in Treating Patients With Recurrent or Refractory Head and Neck Cancer

1995. "Cisplatin Plus Epinephrine in Treating Patients With Recurrent or Refractory Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00002659.

All > Head And Neck Cancer