Aldesleukin Imaging in Viewing Tumor Growth in Patients With Stage IV Melanoma Receiving Ipilimumab Therapy

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 12-003605
    NCT ID: NCT01789827
    Sponsor Protocol Number: MC1274

About this study

This pilot clinical trial studies aldesleukin imaging in viewing tumor growth in patients with stage IV melanoma receiving ipilimumab therapy. New diagnostic procedures, such as single-photon emission computed tomography (SPECT/CT), may be a less invasive way to check for stage IV melanoma. Radioactive drugs, such as technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2, may carry radiation directly to cancer cells and not harm normal cells. Giving 99mTc-HYNIC-IL2 with SPECT/CT may help find tumor growth in patients with stage IV melanoma

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Study closed to enrollment

Inclusion Criteria:

  • Histologic proof of stage IV melanoma (pathology report confirmation) with plans to initiate therapy with ipilimumab according to Food and Drug Administration (FDA) approved guidelines with multiple lesions such that
    • Two of these lesions are in the same organ and at least one of these two lesions is measurable by CT imaging according to RECIST 1.1 OR
    • Three of these lesions are in different organs and at least one of these 3 lesions is measurable by CT imaging according to RECIST 1.1
  • Patient eligible for and will be receiving ipilimumab as standard of care therapy
  • At most 2 prior systematic regimens in the metastatic setting
  • Absolute neutrophil count (ANC) ≥1500 mL
  • Hemoglobin (Hgb) > 10 g/dL
  • Platelets (PLT) ≥ 50,000 mL
  • Aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 3 x ULN*; *up to 5 x allowed for patients with liver metastases
  • Ability to provide informed consent
  • Willingness to return to Mayo Clinic Rochester for follow-up
  • Life expectancy ≥ 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
  • For women of childbearing potential, a negative serum pregnancy test ≤ 7 days prior to registration
  • Willingness to participate in mandatory imaging studies as well as provide mandatory blood samples for correlative research
  • Tumor accessible for biopsy

Exclusion Criteria:

  • Uncontrolled or current infection
  • Known allergy to 99mTc-HYNIC-IL2 or components
  • Any of the following prior therapies with interval since most recent treatment:
    • Chemotherapy ≤ 3 weeks prior to registration
    • Biologic therapy ≤ 3 weeks prior to registration
    • Radiation therapy ≤ 3 weeks prior to registration
  • No more than 3 prior systematic regimens in the metastatic setting
  • Failure to fully recover from side effects of prior chemotherapy or surgery
  • Any of the following, as this regimen may be harmful to a developing fetus or nursing child:
    • Pregnant women
    • Nursing women
    • Women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Svetomir Markovic, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions