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Biomarker Correlates of Hypoxia in Metastatic Melanoma

Primary Purpose

Melanoma, Skin Cancer

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pimonidazole hydrochloride (Hypoxyprobe™-1)
Optional 18F-FMISO PET scan (18F-fluoromisonidazole)
Surgical Resection of Melanoma Metastases
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Melanoma focused on measuring skin cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Must be 18 years or older with a histological diagnosis of locally advanced, recurrent or metastatic melanoma and be scheduled for clinically indicated surgical removal of one or more melanoma tumors. Additionally, patients must have a resectable tumor nodule ≥1 cm^3 (i.e., either a spherical tumor at least 1.0 cm in diameter or a tumor measuring at least 1x1x1 cm). Prior biopsy is not required for study participation.
  • 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:

  • Women who are pregnant or breastfeeding

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Scans, Surgery and Follow-up

    Arm Description

    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).

    Outcomes

    Primary Outcome Measures

    Percentage of Positive Biomarker Staining by Applicable Area
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 10, 2014
    Last Updated
    May 6, 2016
    Sponsor
    H. Lee Moffitt Cancer Center and Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02061007
    Brief Title
    Biomarker Correlates of Hypoxia in Metastatic Melanoma
    Official Title
    Biomarker Correlates of Hypoxia in Metastatic Melanoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    no accrual
    Study Start Date
    October 2014 (undefined)
    Primary Completion Date
    February 2016 (Actual)
    Study Completion Date
    February 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    H. Lee Moffitt Cancer Center and Research Institute

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Melanoma, Skin Cancer
    Keywords
    skin cancer

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Scans, Surgery and Follow-up
    Arm Type
    Experimental
    Arm Description
    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).
    Intervention Type
    Drug
    Intervention Name(s)
    Pimonidazole hydrochloride (Hypoxyprobe™-1)
    Other Intervention Name(s)
    Hypoxyprobe™-1, pimonidazole, HCI, pimo
    Intervention Description
    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).
    Intervention Type
    Drug
    Intervention Name(s)
    Optional 18F-FMISO PET scan (18F-fluoromisonidazole)
    Other Intervention Name(s)
    18F-fluoromisonidazole, 18F-MISO
    Intervention Description
    All patients will be offered the opportunity to receive an additional 18F-FMISO-PET scan, until 18 such scans are administered.
    Intervention Type
    Procedure
    Intervention Name(s)
    Surgical Resection of Melanoma Metastases
    Other Intervention Name(s)
    surgery, resection
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Percentage of Positive Biomarker Staining by Applicable Area
    Description
    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.
    Time Frame
    6 weeks per participant

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Must be 18 years or older with a histological diagnosis of locally advanced, recurrent or metastatic melanoma and be scheduled for clinically indicated surgical removal of one or more melanoma tumors. Additionally, patients must have a resectable tumor nodule ≥1 cm^3 (i.e., either a spherical tumor at least 1.0 cm in diameter or a tumor measuring at least 1x1x1 cm). Prior biopsy is not required for study participation. 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: Women who are pregnant or breastfeeding 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jonathan Zager, M.D.
    Organizational Affiliation
    H. Lee Moffitt Cancer Center and Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Biomarker Correlates of Hypoxia in Metastatic Melanoma

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