Pimonidazole for Melanoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how melanoma in-transit metastases (ITMs) change as they move away from the original tumor. The researchers aim to understand the metabolic (energy use) and immune changes of these lesions, which may help improve treatments. Participants will receive a single dose of pimonidazole, a drug used to study oxygen levels in tumors. This trial may suit those diagnosed with melanoma who have at least two in-transit lesions at different distances from the primary tumor. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potential advancements in melanoma care.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on chronic immunosuppressive drugs, you may not be eligible to participate.
Is there any evidence suggesting that Pimonidazole is likely to be safe for humans?
Research has shown that pimonidazole is generally safe in controlled settings. Safety information indicates potential harm if swallowed in large amounts, though this is unlikely during a clinical trial. With no specific limits for air exposure, it remains safe with good ventilation. If contact occurs with eyes, rinse them with water.
In clinical trials, serious side effects have not been commonly reported. However, monitoring for rare side effects remains important. Overall, evidence suggests that pimonidazole is safe for people when used in controlled doses during a clinical trial.12345Why are researchers excited about this trial?
Pimonidazole is unique because it targets hypoxic cells in in-transit melanoma, a feature that distinguishes it from traditional treatments like surgery, chemotherapy, and immunotherapy. Unlike these standard options, which often target rapidly dividing cells or boost the immune system, pimonidazole specifically binds to low-oxygen tumor areas, potentially allowing for more precise identification and treatment of resistant cancer cells. Researchers are excited about this approach because it could improve the targeting of stubborn melanoma cells, potentially leading to more effective management of the disease.
What evidence suggests that Pimonidazole might be an effective treatment for melanoma in-transit metastases?
Research has shown that pimonidazole, which participants in this trial will receive, helps study low oxygen levels in tumors. It attaches to cells in low-oxygen areas, aiding in the identification of aggressive tumor parts. This ability to highlight these areas might help predict how tumors will respond to treatments like radiotherapy. Although pimonidazole is safe and well-tolerated, it has not yet been proven to directly treat conditions like melanoma. Its primary use is to help researchers better understand tumor environments.678910
Who Is on the Research Team?
Yana Najjar, MD
Principal Investigator
UPMC Hillman Cancer Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Extensive profiling of in-transit melanoma metastases using various imaging and sequencing techniques
Follow-up
Participants are monitored for safety and effectiveness after baseline assessments
What Are the Treatments Tested in This Trial?
Interventions
- Pimonidazole
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Single dose of 0.5 gm/m\^2 of pimonidazole (approximately 13 mg/kg)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yana Najjar
Lead Sponsor
University of Pittsburgh
Lead Sponsor
Hypoxyprobe
Collaborator
Citations
Oral pimonidazole unveils clinicopathologic and epigenetic ...
Oral pimonidazole unveils clinicopathologic and epigenetic features of hypoxic tumour aggressiveness in localized prostate cancer.
Pimonidazole - an overview
Clinical outcome data are still not available for HX4. Although new nitroimidazole-based tracers are still being developed, it is highly unlikely that the ...
3.
aacrjournals.org
aacrjournals.org/cancerres/article/62/23/7066/509392/Pimonidazole-Binding-and-Tumor-Vascularity-PredictPimonidazole Binding and Tumor Vascularity Predict for ...
The association between low VD and poor oxygenation and, consequently unfavorable outcome after radiotherapy, is compatible with the results of this study.
Imaging Mass Spectrometry Revealed the Accumulation ...
These results suggest that in hypoxic tumor cells, pimonidazole is reduced at its nitro group, followed by conjugation with GSH. Citation: Masaki Y, Shimizu Y, ...
NCT06831071 | Evaluation of Hypoxia in Primary Melanoma
Pimonidazole has been previously used in patients and is safe and well tolerated, without anticipated adverse events. What is the study measuring? Primary ...
Safety Data Sheet
Additional ecological information: · General notes: Water hazard class 1 (Self-assessment): slightly hazardous for water. (Contd. on page 6). US ...
7.
file.medchemexpress.com
file.medchemexpress.com/batch_PDF/HY-105129/Pimonidazole-hydrochloride-SDS-MedChemExpress.pdfPimonidazole hydrochloride-SDS- ...
This product contains no substances with occupational exposure limit values. Ensure adequate ventilation. Provide accessible safety shower and eye wash station.
[Pimonidazole Hydrochloride] [CAS# 70132-50-2]
Harmful if swallowed in large quantity. Safety Statements. In case of contact with eyes, rinse immediately with plenty of water and seek medical ...
Pimonidazole - Safety Data Sheet
If inhaled. Move the victim into fresh air. If breathing is difficult, give oxygen. If not breathing, give artificial respiration and consult a doctor ...
Safety Data Sheet
In combustion may emit toxic fumes. No known decomposition information. 11. TOXICOLOGICAL INFORMATION. 11.1 Information on toxicological effects.
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