HD IL-2 + Ipilimumab in Patients With Metastatic Melanoma
NCT ID: NCT01856023
Last Updated: 2023-12-05
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
29 participants
INTERVENTIONAL
2013-05-31
2015-07-31
Brief Summary
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Treatment Arm 1: "HD IL-2 first, then ipilimumab" Patients will receive two courses (four cycles) of High Dose Interleukin-2 (HD IL-2) followed by one course (four doses) of ipilimumab.
Treatment Arm 2: Ipilimumab first then HD IL-2 Patients will receive one course (four doses) of ipilimumab followed by two courses (four cycles) of HD IL-2.
Detailed Description
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Ipilimumab 3mg/kg IV infusion Q3 weeks up to 4 doses4 doses A 3-6 week interval been the administration of the two drugs to allow for resolution of treatment-related toxicities.
If corticosteroids were required during Ipilimumab administration, a 2-week period from discontinuation of steroid treatment to start of HD IL-2.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Treatment Arm 1
Patients will receive two courses (four cycles) of High Dose Interleukin-2 (HD IL-2) followed by one course (four doses) of ipilimumab.
High Dose Interleukin-2
Ipilimumab
Treatment Arm 2
Patients will receive one course (four doses) of ipilimumab followed by two courses (four cycles) of HD IL-2.
High Dose Interleukin-2
Ipilimumab
Interventions
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High Dose Interleukin-2
Ipilimumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed and measurable metastatic melanoma with at least one measurable lesion for evaluation of response
* Meets the requirements for HD IL-2 therapy per Institutional guidelines
* Meets the requirements for ipilimumab therapy per Institutional guidelines
* Treatment naïve or has received only one systemic therapy apart from adjuvant therapy.
* At least 4 weeks since last adjuvant therapy or other cancer treatment
* Willing and able to give informed consent and participate in study procedures as described in the 12PLK02 and 10PLK13 protocols. Patients consented for 12PLK02 will also be asked to participate in the 10PLK13 PROCLAIM registry study.
Exclusion Criteria
* Pregnant, nursing or planning to become pregnant
* Untreated brain metastases. (Brain metastases that have been treated, which no longer require corticosteroid therapy and are without progression by MRI at least 6 weeks after definitive therapy are acceptable.)
* Received prior ipilimumab therapy (Prior Adjuvant Ipilimumab and Adjuvant Interferon are permitted with a minimum 4 week washout)
* Received prior HD IL-2 therapy.
* Received investigational drug within 30 days prior to study dosing. Patients may participate in non-interventional or observational clinical studies, including the 10PLK13 PROCLAIM registry study.
* Concomitant disease or condition that would interfere with the conduct of the study or that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this study.
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Johns Hopkins University
OTHER
Clinigen, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sapna Patel, MD
Role: PRINCIPAL_INVESTIGATOR
MD Anderson
William Sharfman, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
James Lowder, MD
Role: PRINCIPAL_INVESTIGATOR
Prometheus Labs
Locations
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The University of Arizona Cancer Center
Tucson, Arizona, United States
Moores UCSD Cancer Center
La Jolla, California, United States
MSMC Research Program
Miami Beach, Florida, United States
Oncology Specialists, SC
Park Ridge, Illinois, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Johns Hopkins Medicine
Lutherville, Maryland, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Nebraska Cancer Specialists, Midwest Cancer Center - Legacy
Omaha, Nebraska, United States
Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Duke University Health System
Durham, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Other Identifiers
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12PLK02
Identifier Type: -
Identifier Source: org_study_id