Trial record 6 of 37 for:    melanoma | Open Studies | interleukin-2

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by Mayo Clinic
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01789827
First received: February 8, 2013
Last updated: December 3, 2014
Last verified: December 2014
  Purpose

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.


Condition Intervention
Recurrent Melanoma
Stage IV Melanoma
Procedure: scintigraphy
Biological: technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Interleukin-2 Imaging as a Guide to Cancer Immunotherapy (Ipilimumab or MK-3475) in Advanced Melanoma: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Proportion of patients who develop scintigraphy limiting toxicities (SLTs) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]
    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 SLTs will be constructed.


Secondary Outcome Measures:
  • Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 30-45 days after study discontinuation ] [ Designated as safety issue: Yes ]
    The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns.

  • TIL invasion as determined by technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphy [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    Relationship between TIL invasion, tumor burden, tumor based biomarkers, and peripheral blood biomarkers will be assessed.

  • Target-to-background (T/B) ratio as determined by technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphy [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    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 and the change in tumor burden, changes in TIL percentages, and changes in peripheral blood concentrations of T, B, and NK cell subsets.


Estimated Enrollment: 14
Study Start Date: March 2014
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (scintigraphy)
Patients undergo technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphy prior to receiving ipilimumab or pembrolizumab and at 12 weeks.
Procedure: scintigraphy
Undergo technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphies
Biological: technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2
Undergo technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphies
Other Name: 99mTc-HYNIC-IL2
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

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 MK-3475 (pembrolizumab) (expanded access program).

SECONDARY OBJECTIVES:

I. Correlation of tumor infiltrating lymphocyte (TIL) invasion (scintigraphy/histology) with tumor diameter (Response Evaluation Criteria in Solid Tumors [RECIST]); 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 or pembrolizumab and at 12 weeks.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologic proof of stage IV melanoma (pathology report confirmation) with plans to initiate therapy with ipilimumab or MK-3475 according to Food and Drug Administration (FDA) approved guidelines (ipilimumab) or expanded access program (MK-3475) specifications, 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 computed tomography (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 or MK-3475 (enrollment into MK-3475-030 expanded access program is required); Note: only patients eligible for MK-3475-030 would have access to MK-3475 and therefore be eligible for the current study
  • 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 2 prior systematic regimens in the metastatic setting
  • 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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01789827

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015      
Principal Investigator: Svetomir N. Markovic         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Svetomir Markovic Mayo Clinic
  More Information

No publications provided

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT01789827     History of Changes
Other Study ID Numbers: MC1274, NCI-2013-00297, Mod12-003605-14, MC1274, P30CA015083
Study First Received: February 8, 2013
Last Updated: December 3, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Nevi and Melanomas
Interleukin-2
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Analgesics
Analgesics, Non-Narcotic
Antineoplastic Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on March 30, 2015