Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2014-10-31
2016-02-29
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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).
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).
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.
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).
Interventions
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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).
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.
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Not pregnant or nursing (as confirmed by serum pregnancy test if the patient is a woman of child-bearing potential). Participants must agree with use birth control for 30 days following pimonidazole administration.
* Adequate kidney and liver function as assessed by laboratory studies
* Must be able to undergo magnetic resonance imaging (MRI) scans
* Capable of providing informed consent and demonstrate a willingness to comply with all the study procedures and visits
* Eastern Cooperative Oncology Group (ECOG) score of 0 -1
Exclusion Criteria
* Patients who are contraindicated for MRI or gadolinium contrast agents due to:
* Presence of metallic objects or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, skin staples, implanted prostheses, artificial heart valves with steel parts, metal fragments, shrapnel, or other metal implants that would contraindicate MRI)
* Sickle cell disease
* Renal failure with estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m\^2 based upon serum creatinine
* Weight greater than 350 lbs (the weight limit for the MRI)
* Patients with known, active (i.e. not adequately treated with curative intent) malignancies other than melanoma
* Presence of any other co-existing condition which, in the judgment of the investigator, might increase the risk to the participant
18 Years
ALL
No
Sponsors
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H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
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Principal Investigators
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Jonathan Zager, M.D.
Role: PRINCIPAL_INVESTIGATOR
H. Lee Moffitt Cancer Center and Research Institute
Other Identifiers
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MCC-17034
Identifier Type: -
Identifier Source: org_study_id
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