Biomarker Correlates of Hypoxia in Metastatic Melanoma

NCT02061007 | Withdrawn Phase 2

• 1 other identifier: MCC-17034
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Melanoma; Skin Cancer

Keywords

skin cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks per participant

Study Arms (1)

Scans, Surgery and Follow-up

EXPERIMENTAL

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); Drug: Optional 18F-FMISO PET scan (18F-fluoromisonidazole); Procedure: Surgical Resection of Melanoma Metastases

Interventions

Pimonidazole hydrochloride (Hypoxyprobe™-1) DRUG

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).

Also known as: Hypoxyprobe™-1, pimonidazole, HCI, pimo

Scans, Surgery and Follow-up

Optional 18F-FMISO PET scan (18F-fluoromisonidazole) DRUG

All patients will be offered the opportunity to receive an additional 18F-FMISO-PET scan, until 18 such scans are administered.

Also known as: 18F-fluoromisonidazole, 18F-MISO

Scans, Surgery and Follow-up

Surgical Resection of Melanoma Metastases PROCEDURE

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).

Also known as: surgery, resection

Scans, Surgery and Follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

MeSH Terms

Conditions

Melanoma; Skin Neoplasms

Interventions

pimonidazole; fluoromisonidazole; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jonathan Zager, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: February 12, 2014
• Study Start: October 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 9, 2016

Record last verified: 2016-05