Ketoconazole for Cancer-related Rash

No longer recruiting at 7 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Mayo Clinic

Must be taking: EGFR inhibitors

Disqualifiers: Allergy to ketoconazole, sulfites

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of ketoconazole, a cream typically used as an antifungal, in treating rashes caused by EGFR inhibitors, a type of cancer medication. The goal is to determine if ketoconazole can reduce rash symptoms, such as skin burning. Participants will apply either the ketoconazole cream or a placebo cream for 28 days. The trial seeks individuals who have developed a rash from EGFR inhibitor treatments and will continue these treatments for at least another 28 days. As an Early Phase 1 trial, this research aims to understand how ketoconazole works in people, offering participants a chance to contribute to groundbreaking research.

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

The trial does not specify if you need to stop taking your current medications. However, you must continue using an EGFR inhibitor for at least 28 days during the trial.

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

Research has shown that ketoconazole, a medication used for various treatments, can cause some side effects. Some people have experienced skin reactions while using it. It can also lead to liver problems, which is why it is not often the first choice for treating fungal infections today.

However, ketoconazole has demonstrated potential in helping with prostate cancer by reducing certain symptoms. This suggests it might also assist with other issues, such as rashes caused by some cancer treatments. Since this trial is in its early stages, it primarily aims to understand any side effects and how well patients tolerate ketoconazole when used for cancer-related rashes. This phase focuses on safety, and more information will become available as the study progresses. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for cancer-related rash, which often include corticosteroids or antihistamines, ketoconazole offers a novel approach by targeting fungal components that might contribute to the rash. This antifungal agent is applied directly to the skin, potentially reducing inflammation through a different mechanism than traditional treatments. Researchers are excited about ketoconazole because it provides an alternative method of action that could offer relief to patients who don't respond well to conventional therapies, and it might also help minimize systemic side effects due to its topical application.

What evidence suggests that ketoconazole might be an effective treatment for cancer-related rash?

Research has shown that ketoconazole can help manage cancer-related issues. It effectively stops the growth of various cancer cells, potentially alleviating symptoms like rashes from certain cancer treatments. In this trial, one group of participants will apply ketoconazole topically to evaluate its effectiveness in reducing treatment-related rashes. Studies have also found ketoconazole safe and effective for some prostate cancer conditions, as it lowers disease markers like PSA (prostate-specific antigen). These findings suggest ketoconazole might reduce rashes from cancer treatments, offering a promising option for those experiencing side effects from EGFR inhibitors. ^{1 3 6 7 8}

Who Is on the Research Team?

Aminah Jatoi, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for people with a rash or skin burning from EGFR inhibitor cancer treatment, who will continue this treatment for at least 28 days. Participants must be willing to complete quality-of-life questionnaires and may need to provide a skin biopsy. It's not open to those allergic to ketoconazole or sulfites.

Inclusion Criteria

I have a rash or burning skin from EGFR inhibitor treatment.

Mayo only: Patient is willing to provide a skin biopsy for correlative research; Note: Can be waived with permission of study chair (documentation such as an email must be provided)

I will start or continue an EGFR inhibitor treatment for at least 28 days soon.

Exclusion Criteria

You have had a bad reaction to ketoconazole before.

You are allergic or have a bad reaction to sulfites.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants apply ketoconazole or placebo topically twice daily for 28 days

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Ketoconazole

Trial Overview The study tests if ketoconazole can ease rashes caused by EGFR inhibitors in cancer patients. It involves comparing the effects of ketoconazole against a placebo while monitoring participants' quality of life through questionnaires and lab biomarker analysis.

How Is the Trial Designed?

Group I: Arm I (ketoconazole) Experimental Treatment 4 Interventions

Participants apply ketoconazole topically BID on days 1-28.

Group II: Arm II (placebo) Placebo Group 4 Interventions

Participants apply placebo topically BID on days 1-28.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Ketoconazole demonstrated significant cytotoxic effects against various cancer cell lines, with the ability to inhibit 90% of colony growth at specific concentrations, indicating its potential as a treatment option.

The effective concentration of 10 micrograms/ml achievable in humans suggests that ketoconazole warrants further clinical evaluation for its use in treating human malignancies, particularly in breast and pancreatic cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cytotoxicity of ketoconazole in malignant cell lines. Rochlitz, CF., Damon, LE., Russi, MB., et al.[2019]

Citations

1. withpower.com withpower.com/trial/early-phase-1-exanthema-7-2018-78737

Ketoconazole for Cancer-related Rash · Info for Participants Ketoconazole demonstrated significant cytotoxic effects against various cancer cell lines, with the ability to inhibit 90% of colony growth at specific ...

2. mayo.edu mayo.edu/research/clinical-trials/cls-20416406

Ketoconazole in Treating Participants With Ongoing EGFR ... This early phase I trial studies the side effects of ketoconazole and how well it works in treating participants with ongoing EGFR inhibitor-induced rash.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3463372/

Clinical Factors Associated With PSA Response and Disease ... Ketoconazole is effective and safe in mCRPC. Prior response to antiandrogen, pre-treatment PSADT, and disease extent are associated with PSA response and ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2018-00355

Ketoconazole in Treating Participants with Ongoing EGFR ... This early phase I trial studies the side effects of ketoconazole and how well it works in treating participants with ongoing EGFR inhibitor-induced rash.

5. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.1002/cncr.22085

Response to low‐dose ketoconazole and subsequent dose ... Twenty-two (15.9%) patients experienced a PSA decline ≥80% after initiating LDK. The median duration of LDK therapy was longer in responders ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK547869/

Ketoconazole - LiverTox - NCBI Bookshelf - NIH Ketoconazole is a well documented cause of clinically apparent acute drug induced liver injury and is no longer recommended as a first line antifungal agent.

7. mskcc.org mskcc.org/podcasts/cancer-straight-talk/how-to-manage-side-effects-during-cancer-treatment-fatigue-hair-loss

How to Manage Side Effects During Cancer Treatment Learn the most effective ways of preventing or mitigating the side effects of chemotherapy and radiation, including fatigue, hair loss, skin rashes, nausea and ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2090123222001990

Review Repurposing antifungal drugs for cancer therapy Several clinical studies have reported that ketoconazole treatment can induce a decrease in prostate-specific antigen (PSA), relieve clinical symptoms, and ...