Recombinant Interleukin-15 in Treating Patients With Advanced Melanoma, Kidney Cancer, Non-small Cell Lung Cancer, or Squamous Cell Head and Neck Cancer
A Phase 1 Study of Recombinant Human IL15 (rhIL15) in Adults With Advanced Solid Tumors: Melanoma, Renal Cell, Non-Small Cell Lung and Squamous Cell Head and Neck Cancer
3 other identifiers
interventional
20
1 country
5
Brief Summary
This phase I trial studies the side effects and best dose of recombinant interleukin-15 in treating patients with melanoma, kidney cancer, non-small cell lung cancer, or head and neck cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Recombinant interleukin-(IL)15 is a biological product, a protein, made naturally in the body and when made in the laboratory may help stimulate the immune system in different ways and stop tumor cells from growing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2013
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2012
CompletedFirst Posted
Study publicly available on registry
November 15, 2012
CompletedStudy Start
First participant enrolled
February 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2016
CompletedSeptember 15, 2017
September 1, 2017
3.4 years
November 12, 2012
September 14, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
MTD defined as the next lower dose in which 1 or more patients experiences a dose limiting toxicity defined as grade 3 or 4 toxicity graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0
28 days
Secondary Outcomes (9)
ALC, monitored daily during treatment
Up to 6 months
Change in NK cell function measured using flow cytometric analysis of cytokine (IFN-y) secretion and expression of degranulation marker CD107a
Baseline to day 15
Change in presence of auto-antibodies, assessed by ELISA
Baseline to day 4 of week 2
Change in T cell responses to non- physiologic stimuli including PMA
Baseline to day 4 of week 2
Change in T cell subset response to recall viral antigens including CMV and influenza A virus, determined by enzyme-linked immunosorbent spot assay
Baseline to day 4 of week 2
- +4 more secondary outcomes
Study Arms (1)
Treatment (recombinant interleukin-15)
EXPERIMENTALPatients receive recombinant interleukin-15 SC daily on days 1-5 of weeks 1 and 2. Treatment repeats every 28 days (4 weeks) for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Interventions
Given SC
Eligibility Criteria
You may qualify if:
- Patients must have histological or cytological confirmed malignancy in the following disease groups: melanoma, non-small cell lung carcinoma, renal cell carcinoma or squamous cell head and neck carcinoma, for which no standard effective or curative options are available
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Documented evidence of disease progression during 6 month period prior to the time of enrollment
- Prior therapy requirements:
- At least \>= 1 prior completed chemotherapy regimen including chemotherapy, biologic, immunologic or targeted therapy
- At least 4 weeks from last dose of prior chemotherapy with resolution of the acute toxic effects of the therapy
- At least 2 weeks from completion of prior radiation therapy
- At least 4 weeks from last dose of prior investigational therapy
- Not receiving any current anti-cancer therapy
- At least 4 weeks from last dose of interferon or IL-2 therapy
- At least 8 weeks from completion of antibody therapy with anti-checkpoint antibodies, such as anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4) and anti-programmed cell death 1 (PD1)
- At least 4 weeks from last dose of prior other biologic agents
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (Karnofsky \> 70%)
- Absolute lymphocytes \> 500/mcL
- Absolute neutrophil count \> 1,000/mcL
- +22 more criteria
You may not qualify if:
- Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C), or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Class II or greater congestive heart failure as described in the New York Heart Association Functional Classification criteria
- Patients with thyroid disease should be excluded unless their T4 is normal or they are on replacement therapy
- Patients with primary brain cancer or known brain metastases should be excluded from this clinical trial
- Patients who have received prior anti-CTLA4 or anti-PD1 therapy less than 8 weeks prior to enrollment
- Patients who have received prior biologic agents less than 4 weeks prior to enrollment
- Patients who have received prior interferon or IL-2 therapy less than 4 weeks prior to enrollment
- ECOG score greater than 1 (Karnofsky \< 70%)
- HIV-positive patients
- Positive hepatitis C serology
- Patients who are receiving any other investigational agents
- Inability to home monitor blood pressure
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304, United States
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Related Publications (2)
Margolin K, Morishima C, Velcheti V, Miller JS, Lee SM, Silk AW, Holtan SG, Lacroix AM, Fling SP, Kaiser JC, Egan JO, Jones M, Rhode PR, Rock AD, Cheever MA, Wong HC, Ernstoff MS. Phase I Trial of ALT-803, A Novel Recombinant IL15 Complex, in Patients with Advanced Solid Tumors. Clin Cancer Res. 2018 Nov 15;24(22):5552-5561. doi: 10.1158/1078-0432.CCR-18-0945. Epub 2018 Jul 25.
PMID: 30045932DERIVEDMiller JS, Morishima C, McNeel DG, Patel MR, Kohrt HEK, Thompson JA, Sondel PM, Wakelee HA, Disis ML, Kaiser JC, Cheever MA, Streicher H, Creekmore SP, Waldmann TA, Conlon KC. A First-in-Human Phase I Study of Subcutaneous Outpatient Recombinant Human IL15 (rhIL15) in Adults with Advanced Solid Tumors. Clin Cancer Res. 2018 Apr 1;24(7):1525-1535. doi: 10.1158/1078-0432.CCR-17-2451. Epub 2017 Dec 4.
PMID: 29203590DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey Miller
Cancer Immunotherapy Trials Network
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2012
First Posted
November 15, 2012
Study Start
February 15, 2013
Primary Completion
June 30, 2016
Study Completion
June 30, 2016
Last Updated
September 15, 2017
Record last verified: 2017-09