Microdevice for Skin Cancer
(SCC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to treat squamous cell carcinoma, a type of skin cancer, using a small device called a Microdevice. This device delivers drugs directly to the affected area. Researchers examine how different drugs impact the cancer when applied locally and systemically. Participants should have a visible skin lesion that a doctor can easily access and confirm as squamous cell carcinoma. This trial may suit those planning surgery or systemic therapy for their skin cancer. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.
Do I have to stop taking my current medications for the trial?
The trial does not require a washout period (time without taking certain medications) from previous treatments, so you likely won't need to stop your current medications. However, if you are in the expansion cohort receiving systemic therapy, you cannot start new skin-directed therapies at the same time as your first systemic therapy.
What prior data suggests that this microdevice is safe for treating squamous cell carcinoma?
Research has shown that using a small device to test drugs on skin lesions is generally safe. In an initial trial, the device released drugs only to the tumor area. The drug amounts were very tiny—one millionth of the usual dose—reducing the chance of side effects. Earlier studies found that patients tolerated the device well, with few negative effects. The device can hold up to 20 different drugs, allowing doctors to test treatments directly on the tumor safely and effectively. Although the trial remains in the early stages, the device has shown promise in being safe for use in people.12345
Why are researchers excited about this trial's treatments?
Most treatments for skin cancer involve surgical procedures like Mohs surgery or local excision, often combined with radiation or systemic therapies. However, researchers are excited about the microdevice because it offers a new delivery method that can be directly implanted into the skin to target the cancer more precisely. This technique allows for personalized treatment by analyzing the tumor's response to the microdevice and adjusting the therapy accordingly. By potentially optimizing the treatment protocol based on individual tumor characteristics, this approach could enhance effectiveness and reduce side effects compared to traditional methods.
What evidence suggests that this microdevice is effective for squamous cell carcinoma?
This trial will evaluate a microdevice for skin cancer treatment. Studies have shown that microneedle patches for chemotherapy delivery appear promising. In earlier research, the highest dose tested caused 73% of tumors to visibly shrink or disappear in many patients. Another study found that patients tolerated the microneedle patches well, and a specific effective dose was identified. This technology aims to deliver drugs directly into the skin, potentially targeting cancer cells more precisely. Although still under study, early results suggest it might effectively treat squamous cell carcinoma (SCC). Participants in the local treatment cohort will receive the microdevice alongside local surgical interventions, while those in the systemic treatment cohort will receive systemic therapy, with the potential for additional microdevice implantation if residual disease remains.16789
Are You a Good Fit for This Trial?
This trial is for adults (18+) with visible skin lesions from squamous cell carcinoma, including those with metastatic disease involving the skin. Participants must be well enough to care for themselves and have a lesion at least 1 cm wide that can hold the device. People with controlled HIV, hepatitis B, or cured/treated hepatitis C may join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive standard-of-care treatment for SCC with the addition of a microdevice for drug screening, which is implanted and removed after 3-5 days
Follow-up
Participants are monitored for safety and effectiveness after treatment, including analysis of microdevice results
Systemic Treatment Cohort
Participants receive systemic therapy, and additional microdevices may be implanted if residual disease is present after 12 weeks
What Are the Treatments Tested in This Trial?
Interventions
- Microdevice
Trial Overview
Researchers are testing a small microdevice placed in a skin tumor to deliver different drugs directly into the lesion. The goal is to see how these drugs affect squamous cell carcinoma cells in the skin.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Systemic Treatment Cohort (20 patients) will not enroll until initial cohort has been completed (MD have been implanted, retrieved, and processed for immunohistochemical analysis). Microdevice protocol will be optimized given results derived from the local treatment cohort. Will include participants who plan to receive systemic therapy in the absence of additional local therapy (surgery or radiation). If patients receive systemic therapy, and there is clinical cutaneous residual disease after 12 weeks of systemic therapy, an additional 1 to 4 MDs will be implanted into residual cutaneous disease at this time.
Local Treatment Cohort (5 participants) may recruit participants who plan to receive local surgical intervention (Mohs surgery or local excision) alone or in combination with further surgical treatment, radiation, or systemic therapy.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Oliver Jonas
Lead Sponsor
Dana-Farber Cancer Institute
Collaborator
Citations
Advancements in skin cancer treatment: focus on ... - PMC - NIH
Both treatments outperformed vehicle-PDT by a substantial margin. Interestingly, compared to patients who underwent the 3-hour incubation, those who underwent ...
2.
newswise.com
newswise.com/articles/microneedle-patch-delivering-chemotherapy-shows-promise-against-common-skin-cancer-in-phase-2-trialMicroneedle Patch Delivering Chemotherapy Shows ...
Biotech company Medicus Pharma reported that the highest dose tested in the study achieved 73% clinical tumor clearance and 40% histological ...
Long-term clinical outcomes of non-melanoma skin cancer ...
Electronic brachytherapy for the treatment of non-melanoma skin cancer is safe and effective, showing excellent long-term 98.9% of local control, with a median ...
Skin Cancer Cure Rate Research | Treatments For ...
Research shows GentleCure Image-Guided SRT cures over 99% of basal and squamous cell skin cancers. Learn about this surgery-free treatment.
The EPIC Study: A new era in non-surgical skin cancer ...
At 12 months, the overall response rate was 97.3% and a complete response rate (i.e. that the tumour has been cured) of ~95%. When we looked at ...
Microdevice for In Situ Candidate Drug Screening in Skin ...
This pilot trial studies the side effects and feasibility of microdevice for in situ candidate drug screening in skin lesions of T-cell lymphoma. Implanting ...
Drug Screening of Cutaneous Lesions of Squamous Cell ...
The microdevice can hold up to 20 drugs in very small concentrations that are able to access the cancer through small pores in the device. When the device is ...
Radiotherapeutic Modalities and Advancements in the ...
BT offers a highly conformal treatment option for cutaneous malignancies, particularly in elderly or surgically ineligible patients, and is especially useful ...
9.
clinicaltrial.be
clinicaltrial.be/en/details/62174?active_not_recruiting=1&completed=0&enrolling_by_invitation=1¬_yet_recruiting=0&only_eligible=0&per_page=20&recruiting=1A Pilot of a Microdevice For In Situ Candidate Drug Scree...
The microdevice was able to release drugs only to the immediately surrounding tumor tissue in concentrations of one millionth of what is ...
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