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Half the chemo, same punch? trial tests lower bleomycin dose for skin tumors

NCT ID NCT06647342

Disease control Sponsor: Julie Gehl Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers test whether halving the bleomycin dose in electrochemotherapy controls skin tumors as well as the standard dose. Electrochemotherapy gives chemotherapy followed by brief electrical pulses that help the drug enter tumor cells. Adults with cutaneous or subcutaneous cancer receive one treatment session with either the full or reduced dose. Doctors measure tumor size before treatment and three months later to compare response rates.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bleomycin, a chemotherapy drug used with electrochemotherapy
What this could lead to
If the lower dose works as well, people with skin tumors could get the same tumor response with less chemotherapy and fewer side effects.
What could go wrong
The lower dose might not control tumors as well as the standard dose. This is a small trial, and results may not apply to all skin tumor types.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 55 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Trial subject \> 18 years. 2. Trial subject must be able to understand the participant information. 3. Histologically verified cutaneous or subcutaneous, primary or secondary cancer of any histology. 4. Life expectancy \> 3 months. 5. Trial subject can undergo simultaneous medical treatment (endocrine therapy, chemotherapy, immunotherapy, etc.) at any point during the study. 6. Trial subject may have received ECT treatment previously if selected tumours have not received ECT or if a minimum of 3 months after ECT treatment have passed. 7. Trial subject can undergo radiation therapy, provided that the treatment field does not involve the area intended to treat. If the trial subject has received radiation therapy in the area intended to treat, a minimum of 3 months should have passed. 8. A creatinine level within normal upper limit. If creatinine is above normal upper limit the subject needs to have a creatinine clearance \> 50 ml/min. 9. Both men and women who are sexually active must use safe contraception. This includes the use of intrauterine device (IUD), oral contraceptives, male or female condom, vasectomy or female sterilization. 10. Signed informed consent. Exclusion Criteria: 1. Pregnancy or lactation. All fertile women will have to deliver a negative pregnancy test before ECT treatment. 2. Allergy or hypersensitivity to bleomycin. 3. Acute lung infection. 4. Severely impaired lung function or any lung condition the investigator deems severe. 5. Any other caution, clinical disease or previous treatments that make the investigator deem the trial subject unfit. 6. The cumulative bleomycin dose must not exceed the by the drug manufacturer recommended maximum dose.

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Conditions

The condition(s) this trial relates to.

skin neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bleomycin adverse reaction Cutaneous malignant mixed tumor Cutaneous metastasis Electrochemotherapy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Copenhagen University Hospital Herlev-Gentofte

    RECRUITING

    Herlev, 2730, Denmark

  • Zealand University Hospital

    RECRUITING

    Roskilde, 4000, Denmark

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