Interleukin-2 Imaging As A Guide To Cancer Immunotherapy (Ipilimumab) In Advanced Melanoma: A Pilot Study
18 Years
N/A
Both
Recurrent Melanoma, Stage IV Melanoma
Trial Information
Interleukin-2 Imaging As A Guide To Cancer Immunotherapy (Ipilimumab) In Advanced Melanoma: A Pilot Study
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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.
TERTIARY OBJECTIVES:
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.
OUTLINE:
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
years.
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.)
Type of Study:
Interventional
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:
Yes
Principal Investigator
Svetomir Markovic
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Food and Drug Administration
Study ID:
MC1274
NCT ID:
NCT01789827
Start Date:
April 2013
Completion Date:
Related Keywords:
- Recurrent Melanoma
- Stage IV Melanoma
- Melanoma
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
