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AzTrials

Stage IV Skin MelanomaEarly Phase 1NCT01789827

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

A Early Phase 1 study testing Laboratory Biomarker Analysis, Radionuclide Imaging and Technetium Tc 99 Hydrazinonicotinamide-Tricine-linked Interleukin-2 in people with Stage IV Skin Melanoma, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stage IV Skin Melanoma
What is being tested?
Laboratory Biomarker Analysis, Radionuclide Imaging and Technetium Tc 99 Hydrazinonicotinamide-Tricine-linked Interleukin-2
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
Mar 2014to 27 Jun 2018
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 16Show fewer
  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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.)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Interleukin-2 Imaging as a Guide to Cancer Immunotherapy (Ipilimumab or Pembrolizumab) in Advanced Melanoma: A Pilot Study

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. Correlation of tumor infiltrating lymphocyte (TIL) invasion (scintigraphy/histology) with tumor burden; and description of any clinical side effects associated with imaging.

TERTIARY OBJECTIVES:

  1. 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.

Being tested
Laboratory Biomarker Analysis, Radionuclide Imaging, Technetium Tc 99 Hydrazinonicotinamide-Tricine-linked Interleukin-2
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Radionuclide ImagingProcedure or surgery

    Also called nuclear medicine scan, radioimaging, Radionuclide Scanning, Scan

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

  • Technetium Tc 99 Hydrazinonicotinamide-Tricine-linked Interleukin-2Biological

    Also called 99mTc-HYNIC-IL2

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

Study groups in NCT01789827
Study groupRoleWhat they receive
Cohort I (scintigraphy prior to immunotherapy and 12 weeks)ExperimentalPatients undergo technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphy prior to receiving ipilimumab or pembrolizumab and at 12 weeks.
Receives: 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)ExperimentalPatients undergo technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphy prior to receiving ipilimumab or pembrolizumab, at 3-4 weeks, and at 12 weeks.
Receives: Other: Laboratory Biomarker Analysis; Procedure: Radionuclide Imaging; Biological: Technetium Tc 99 Hydrazinonicotinamide-Tricine-linked Interleukin-2

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 12 weeks

Secondary outcomes (3)

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

    The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns.

    Measured: Up to 30-45 days after study discontinuation

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

    Spearman rank correlation coefficients will be used to examine the association between T/B ratio and the pre-treatment tumor biomarkers. Spearman rank correlation coefficients will be used to examine the association between changes in T/B ratio, changes in TIL percentages, and changes in peripheral blood concentrations of T, B, and NK cell subsets.

    Measured: Up to 12 weeks

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

    Relationship between TIL invasion, tumor burden, tumor based biomarkers, and peripheral blood biomarkers will be assessed.

    Measured: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2013 (estimated)
  2. Study startMar 2014
  3. Primary completion27 Jun 2018
  4. Study completion27 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01789827
Sponsor's protocol ID
MC1274
Other IDs
NCI-2013-00297, Mod12-003605-14, MC1274, P30CA015083
Status last verified
Apr 2019
First submitted
8 Feb 2013
Last updated
5 Aug 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Laboratory Biomarker Analysis, Radionuclide Imaging and Technetium Tc 99 Hydrazinonicotinamide-Tricine-linked Interleukin-2 in people with Stage IV Skin Melanoma, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who develop scintigraphy limiting toxicities (SLTs) (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01789827.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.

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