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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2018-06-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Imiquimod and Pembrolizumab in Treating Patients With Stage IIIB-IV Melanoma

NCT03276832

Metastatic Melanoma Stage IIIB Cutaneous Melanoma AJCC v7 Stage IIIC Cutaneous Melanoma AJCC v7 +1 more

COMPLETED EARLY_PHASE1

A Phase II Study to Evaluate Safety and Efficacy of Combined Treatment With Ipilimumab and Intratumoral Interleukin-2

NCT01480323

Malignant Melanoma

COMPLETED PHASE2

Radiation Therapy, Plasma Exchange, and Immunotherapy (Pembrolizumab or Nivolumab) for the Treatment of Melanoma

NCT04581382

Melanoma

COMPLETED EARLY_PHASE1

Radiation and Combination Immunotherapy for Melanoma

NCT03850691

Metastatic Melanoma

COMPLETED PHASE2

Phase II Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Treating Patients With Stage IV Melanoma

NCT01970527

Recurrent Melanoma Stage IV Skin Melanoma

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVES:

I. Feasibility/biodistribution of 99mTc-HYNIC-IL2 (technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin 2) scintigraphy in patients with metastatic melanoma undergoing immunotherapy with either ipilimumab (commercial source) or pembrolizumab.

SECONDARY OBJECTIVES:

I. Correlation of tumor infiltrating lymphocyte (TIL) invasion (scintigraphy/histology) with tumor burden; 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 are assigned to 1 of 2 groups. COHORT I: Patients undergo technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphy prior to receiving ipilimumab or pembrolizumab and at 12 weeks.

COHORT II: 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.

After completion of study treatment, patients are followed up at 30-45 days.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stage IV Skin Melanoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort I (scintigraphy prior to immunotherapy and 12 weeks)

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

Group Type EXPERIMENTAL

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Radionuclide Imaging

Intervention Type PROCEDURE

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

Technetium Tc 99 Hydrazinonicotinamide-Tricine-linked Interleukin-2

Intervention Type BIOLOGICAL

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

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

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.

Group Type EXPERIMENTAL

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Radionuclide Imaging

Intervention Type PROCEDURE

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

Technetium Tc 99 Hydrazinonicotinamide-Tricine-linked Interleukin-2

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Radionuclide Imaging

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

Intervention Type PROCEDURE

Technetium Tc 99 Hydrazinonicotinamide-Tricine-linked Interleukin-2

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

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

nuclear medicine scan radioimaging Radionuclide Scanning Scan SCINTIGRAPHY 99mTc-HYNIC-IL2

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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
* 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
* 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.)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No