Clinical trial NCT01415167: PROCLAIM Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy
Official title: Proleukin Observational Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Renal Cell Carcinoma
Metastatic Melanoma
Lead sponsor: Prometheus Laboratories
Sponsor class: INDUSTRY
First posted: 2011-08-11
Enrollment: 1690
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients starting high dose IL-2 or Proleukin therapy are eligible to participate

Brief summary: The purpose of this registry is to collect information on patients who are receiving treatment with Proleukin in an organized way, and to learn more about patient care during and after treatment.

Detailed description: The PROCLAIM Registry is a US-based, multicenter Registry designed to establish a high quality observational database of real-world clinical data on HD IL-2 when used to treat patients with mRCC, mM or other malignancies. The Registry will not, in any way, suggest changes in the treatment or management of the patients enrolled in the Registry. Therefore, physicians will continue to manage and treat patients according to standard of care and their own judgment.

The PROCLAIM Registry will start with a retrospective pilot data collection from a de-identified finite number of patient cases abstracted from their existing medical charts. The features collected will be identical to those planned for the prospective registry. The resulting database will be used to formulate hypotheses to be tested using the prospective registry database. Patients utilized in the retrospective analysis will be excluded from the prospective portion of the Registry.

In the prospective portion of the Registry, sites will enroll patients who are expected to start a course of HD IL-2 therapy. Once enrolled, the patient must receive at least one dose of HD IL-2 to remain in the Registry. Patients will be treated and followed according to the site's standard of care. This Registry will in no way induce changes in the management of individual patients. Clinical data features will be entered into an Electronic Data Capture (EDC) system, and organized into a registry database.

The data contained in the registry database will be observational data. The PROCLAIM Registry does not stipulate patient care, specific visits or interventions but merely surveys standardized parameters regarding HD IL-2 and associated therapies as they are applied by treatment centers. The collection of standard data over time permits the evaluation of trends in patient survival and subsequent therapy exposure. The database will be used to answer future queries formulated by researchers.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Must have received at least one course of high dose IL-2 or Proleukin
* Signed informed consent form

Exclusion Criteria:

* Prior high dose IL-2 or Proleukin therapy

Primary outcomes:
measure: A source of observational data that can be used to report and query patient care patterns, clinical outcomes and trends from high dose IL-2 or Proleukin therapy in treating malignant melanoma, or renal cell carcinoma or other malignancies.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: The University of Arizona Cancer Center
state: Arizona
city: La Jolla
country: United States
facility: Moores UCSD Cancer Center
state: California
city: Los Angeles
country: United States
facility: USC Norris Cancer Center
state: California
city: Riverside
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center Comprehensive Cancer Center
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University Winship Cancer Institute
state: Georgia
city: Honolulu
country: United States
facility: University of Hawaii
state: Hawaii
city: Chicago
country: United States
facility: Rush Pres St Lukes Medical Center
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Park Ridge
country: United States
facility: Oncology Specialists, SC
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Center
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Baton Rouge
country: United States
facility: The Baton Rouge Clinic, AMC
state: Louisiana
city: Lutherville
country: United States
facility: Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Masonic Cancer Center
state: Minnesota
city: Saint Louis
country: United States
facility: Saint Louis University Cancer Center
state: Missouri
city: Omaha
country: United States
facility: Midwest Cancer Center - Legacy
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: New York
country: United States
facility: Saint Luke's-Roosevelt Hospital Center
state: New York
city: New York
country: United States
facility: Columbia University/Herbert Irving Comprehensive Cancer Center
state: New York
city: Syracuse
country: United States
facility: The Research Foundation for The State University of New York
state: New York
city: Charlotte
country: United States
facility: Blumenthal Cancer Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital Cancer Center
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Cancer Institute
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Siedman Cancer Center
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Bethlehem
country: United States
facility: Saint Luke's Hospital and Health Network
state: Pennsylvania
city: Hershey
country: United States
facility: The Pennsylvania State University and The Milton S. Hershey Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Hillman Cancer Research Pavilion, Div. of Medical Oncology
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Franklin
country: United States
facility: Wheaton Franciscan Cancer Care
state: Wisconsin
Study officials:
affiliation: MD Anderson
name: Michael Wong, MD
role: STUDY_CHAIR
References:
citation: Fishman M, Dutcher JP, Clark JI, Alva A, Miletello GP, Curti B, Agarwal N, Hauke R, Mahoney KM, Moon H, Treisman J, Tykodi SS, Daniels G, Morse MA, Wong MKK, Kaufman H, Gregory N, McDermott DF. Overall survival by clinical risk category for high dose interleukin-2 (HD IL-2) treated patients with metastatic renal cell cancer (mRCC): data from the PROCLAIMSM registry. J Immunother Cancer. 2019 Mar 27;7(1):84. doi: 10.1186/s40425-019-0567-3.
citation: Curti B, Daniels GA, McDermott DF, Clark JI, Kaufman HL, Logan TF, Singh J, Kaur M, Luna TL, Gregory N, Morse MA, Wong MKK, Dutcher JP. Improved survival and tumor control with Interleukin-2 is associated with the development of immune-related adverse events: data from the PROCLAIMSM registry. J Immunother Cancer. 2017 Dec 19;5(1):102. doi: 10.1186/s40425-017-0307-5.