Biomarker Correlates of Hypoxia in Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT02061007|
Recruitment Status : Withdrawn (no accrual)
First Posted : February 12, 2014
Last Update Posted : May 9, 2016
The purpose of this study is to determine if magnetic resonance imaging (MRI) or positron emission tomography (PET) imaging can be used to help doctors determine how much oxygen a tumor is getting. Hypoxyprobe will be used to determine the levels of oxygen post-surgery in the current study. If the study is successful, then imaging can be used to determine a tumor's oxygen status even in patients who are not getting surgery.
Investigators want to find out how much oxygen is in the participants tumor based on how much pimo is present, and correlate this with the results of their MRI and 18F-fluoromisonidazole (FMISO) PET scan.
This study is also testing the investigational radioactive substance known as FMISO. FMISO is used during PET scans to help doctors see how much oxygen a tumor is getting. Participants might be asked to participate in an optional PET scan using FMISO.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Skin Cancer||Drug: Pimonidazole hydrochloride (Hypoxyprobe™-1) Drug: Optional 18F-FMISO PET scan (18F-fluoromisonidazole) Procedure: Surgical Resection of Melanoma Metastases||Phase 2|
A pilot phase II imaging study to determine hypoxia in melanoma.
About 16 - 24 hours before surgery, participants will be asked to come to the study center to take the investigational agent oral pimonidazole (pimo) by mouth. Pimo is a substance that is able to enter tissue when there are low levels of oxygen present (hypoxia). When the tissue is removed and visualized under a microscope, the amount of pimo present is related to the amount of oxygen in that part of the tissue. The dose of pimo given to the participant will depend on their weight (13 mg pimo/kg body weight).
After surgery, a sample of the participant's tumor tissue will be viewed by doctors under a microscope to determine the amount of pimo present.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Biomarker Correlates of Hypoxia in Metastatic Melanoma|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
Experimental: Scans, Surgery and Follow-up
Pre-surgery scans, surgical resection and post-surgery follow-up. All patients will receive a fluorodeoxyglucose (FDG)-PET scan as part of standard of care. This scan must be completed within 28 days of surgery for the patient to be eligible. All patients will be offered the opportunity to receive an additional 18F-FMISO-PET scan, until 18 such scans are administered. Prior to surgery, patients will be administered a single dose of 0.5 g/m^2 (approximately 13 mg/kg) of oral Hypoxyprobe™-1 (pimonidazole, HCl).
Drug: Pimonidazole hydrochloride (Hypoxyprobe™-1)
Prior to surgery, patients will be administered a single dose of 0.5 g/m^2 (approximately 13 mg/kg) of oral Hypoxyprobe™-1 (pimonidazole, HCl).
Drug: Optional 18F-FMISO PET scan (18F-fluoromisonidazole)
All patients will be offered the opportunity to receive an additional 18F-FMISO-PET scan, until 18 such scans are administered.
Procedure: Surgical Resection of Melanoma Metastases
Participants will undergo surgical resection of melanoma metastases within 16 - 24 hours of consuming oral pimonidazole. Pimonidazole staining will be done on formalin-fixed and paraffin-embedded (FFPE) tissues for pimonidazole analysis. All participants will be contacted 24-72 hours post-surgery to be assessed for any adverse events (AEs) related to surgery, pimonidazole consumption and 18F-FMISO (when applicable).
- Percentage of Positive Biomarker Staining by Applicable Area [ Time Frame: 6 weeks per participant ]Relationship between MRI and/or FMISO-PET imaging features and pimonidazole staining by immunohistochemical analysis in melanoma metastases. Investigators expect that the correlation between them is at least 0.45. With a 5% significance level, a total of 36 participants will provide 81% power to test a null hypothesis correlation of 0 versus an alternative hypothesis correlation of 0.45 using a two-sided test.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061007
|Principal Investigator:||Jonathan Zager, M.D.||H. Lee Moffitt Cancer Center and Research Institute|