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Interleukin-2 Imaging As A Guide To Cancer Immunotherapy (Ipilimumab) In Advanced Melanoma: A Pilot Study

18 Years
Not Enrolling
Recurrent Melanoma, Stage IV Melanoma

Thank you

Trial Information

Interleukin-2 Imaging As A Guide To Cancer Immunotherapy (Ipilimumab) In Advanced Melanoma: A Pilot Study


I. Feasibility/biodistribution of 99mTc-HYNIC-IL2 (technetium Tc 99
hydrazinonicotinamide-tricine-linked interleukin 2) scintigraphy in patients with metastatic
melanoma undergoing ipilimumab (IPI) therapy.


I. Correlation of tumor infiltrating lymphocyte (TIL) invasion (scintigraphy/histology) with
tumor diameter (Response Evaluation Criteria in Solid Tumors [RECIST]); description of
survival end points(progression free survival [PFS]/overall survival [OS] and 2 year
survival rate); and description of any clinical side effects associated with imaging.


I. Correlation of TIL invasion assessed by 99mTc-HYNIC-IL2 scintigraphy vs histology (total
and subsets of TIL), as well as screen for peripheral blood correlates.


Patients undergo technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2
scintigraphy prior to receiving ipilimumab therapy and at 12 weeks.

After completion of study treatment, patients are followed up every 3 months for up to 2

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

- 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

- 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.)

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Proportion of patients who develop a SLD (grade 2+ allergic reaction; grade 3+ anaphylaxis, grade 2+ injection site reaction, or a grade 3+ non-hematologic toxicity -not attributed to IPI treatment/progression or a co-morbid condition)

Outcome Description:

95% binomial confidence interval will be constructed

Outcome Time Frame:

Up to 12 weeks

Safety Issue:


Principal Investigator

Svetomir Markovic

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

April 2013

Completion Date:

Related Keywords:

  • Recurrent Melanoma
  • Stage IV Melanoma
  • Melanoma



Mayo Clinic Rochester, Minnesota  55905