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Anti-tumor antibiotic

Bleomycin with Electroporation Therapy for Melanoma

Phase 1

Waitlist Available

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

Must not have previously exceeded or will exceed on this study a cumulative dose greater than 400 U of bleomycin

At least 12 weeks since prior local cryotherapy to study lesion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying giving bleomycin with or without electroporation therapy to see how well it works in treating patients with stage III or stage IV melanoma.

Who is the study for?

This trial is for adults over 18 with stage III or IV melanoma that hasn't responded to other treatments, or they can't have those treatments. They should have measurable disease and at least two lesions suitable for electroporation therapy. Participants need functioning kidneys and a life expectancy over six months. Those with heart devices, severe allergies to bleomycin or lidocaine, recent cancers (except certain skin cancers), or untreated infections cannot join.Check my eligibility

What is being tested?

The study is testing the effectiveness of the chemotherapy drug Bleomycin in combination with electroporation therapy—a technique that may help chemo drugs enter tumor cells better—against using Bleomycin alone in patients with advanced melanoma.See study design

What are the potential side effects?

Bleomycin can cause lung problems like coughing or shortness of breath, skin reactions, fever, weight loss, and fatigue. Electroporation might lead to discomfort at the treatment site. The full range of side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

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I have not received more than 400 units of bleomycin.

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It has been over 12 weeks since I had cryotherapy on my cancer lesion.

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I have never had a severe irregular heartbeat.

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I have at least 2 tumors that can be reached for treatment with an electrode.

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I am 18 years old or older.

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My melanoma is confirmed to be at stage III or IV.

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My cancer is advanced and hasn't responded to or can't be treated with standard therapies.

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I have not had a heart attack in the last 6 months.

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 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

542 Previous Clinical Trials

135,492 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,272 Total Patients Enrolled

Ronald C. DeConti, MDStudy ChairH. Lee Moffitt Cancer Center and Research Institute

Media Library

Bleomycin (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT00006035 — Phase 1

Skin Cancer Clinical Trial 2023: Bleomycin Highlights & Side Effects. Trial Name: NCT00006035 — Phase 1

Bleomycin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00006035 — Phase 1

Frequently Asked Questions

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

Has this form of intervention been granted authorization from the FDA?

"The safety rating of this treatment was assessed to be a 1 by our team at Power, as it is still in the first phase of research and thus there is only limited data confirming efficacy and security."

Answered by AI

Is enrollment currently open for this research endeavor?

"According to clinicaltrials.gov, the posting for this medical trial is inactive; it was first published on June 1st 2000 and last updated September 16th 2013. Nevertheless, there are still 757 other trials actively seeking participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Bleomycin With or Without Electroporation Therapy in Treating Patients With Stage III or Stage IV Melanoma

2000. "Bleomycin With or Without Electroporation Therapy in Treating Patients With Stage III or Stage IV Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00006035.

All > Stage Iv Melanoma