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

NCT01789827 | Completed Early Phase 1 DMC

• 4 other identifiers: MC1274NCI-2013-00297Mod12-003605-14P30CA015083
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies aldesleukin imaging in viewing tumor growth in patients with stage IV melanoma receiving ipilimumab or pembrolizumab therapy. Diagnostic procedures, such as single-photon emission computed tomography (SPECT), uses radioactive drugs and a scanner to make detailed pictures of areas inside the body and may be a less invasive way to check for stage IV melanoma. Radioactive drugs, such as technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2, carry radiation directly to cancer cells and may be able to differentiate between tumor growth due to inflammation versus tumor progression in patients with stage IV melanoma receiving therapy.

Conditions

Stage IV Skin Melanoma

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who develop scintigraphy limiting toxicities (SLTs)

  SLTs include grade 2+ allergic reaction, grade 3+ anaphylaxis, grade 2+ injection site reaction, or grade 3+ non-hematologic toxicity (not attributed to immunotherapy treatment/progression or a co-morbid condition). A 95% binomial confidence interval of the proportion of patients who develop a grade 2+ allergic reaction, grade 3+ anaphylaxis, or grade 2+ injection site reaction will be constructed.

  Up to 12 weeks

Secondary Outcomes (3)

• Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

  Up to 30-45 days after study discontinuation

• Target-to-background (T/B) ratio as determined by technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphy

  Up to 12 weeks

• TIL invasion as determined by technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphy

  Up to 12 weeks

Study Arms (2)

Cohort I (scintigraphy prior to immunotherapy and 12 weeks)

EXPERIMENTAL

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

Other: Laboratory Biomarker Analysis; Procedure: Radionuclide Imaging; Biological: Technetium Tc 99 Hydrazinonicotinamide-Tricine-linked Interleukin-2

Cohort II (scintograpy prior to immunotherapy, 3-4, 12 weeks)

EXPERIMENTAL

Patients undergo technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphy prior to receiving ipilimumab or pembrolizumab, at 3-4 weeks, and at 12 weeks.

Other: Laboratory Biomarker Analysis; Procedure: Radionuclide Imaging; Biological: Technetium Tc 99 Hydrazinonicotinamide-Tricine-linked Interleukin-2

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Cohort I (scintigraphy prior to immunotherapy and 12 weeks); Cohort II (scintograpy prior to immunotherapy, 3-4, 12 weeks)

Radionuclide Imaging PROCEDURE

Undergo technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphies

Also known as: nuclear medicine scan, radioimaging, Radionuclide Scanning, Scan, SCINTIGRAPHY

Cohort I (scintigraphy prior to immunotherapy and 12 weeks); Cohort II (scintograpy prior to immunotherapy, 3-4, 12 weeks)

Technetium Tc 99 Hydrazinonicotinamide-Tricine-linked Interleukin-2 BIOLOGICAL

Undergo technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphies

Also known as: 99mTc-HYNIC-IL2

Cohort I (scintigraphy prior to immunotherapy and 12 weeks); Cohort II (scintograpy prior to immunotherapy, 3-4, 12 weeks)

Eligibility Criteria

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

You may qualify if:

• Pathologic proof of stage IV melanoma (pathology report confirmation) with plans to initiate therapy with ipilimumab or pembrolizumab 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 Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 using either intravenous (IV) contrast enhanced computed tomography (CT) or CT component of positron emission tomography (PET)/CT OR
• Three of these lesions are in different organs and at least one of these 3 lesions is measurable by RECIST 1.1 using either IV contrast enhanced CT or CT component of PET/CT
• Patient eligible for and will be receiving ipilimumab or pembrolizumab as standard of care therapy
• 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

You may not qualify if:

• 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
• Failure to recover from side effects of prior chemotherapy or surgery
• Any of the following:
• 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.)

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Svetomir Markovic

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2013
• First Posted: February 12, 2013
• Study Start: March 1, 2014
• Primary Completion: June 27, 2018
• Study Completion: June 27, 2018
• Last Updated: August 5, 2019

Record last verified: 2019-04

Locations

US (1)