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PROCLAIM Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy

Information source: Prometheus Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Renal Cell Carcinoma; Metastatic Melanoma

Phase: N/A

Status: Recruiting

Sponsored by: Prometheus Laboratories

Official(s) and/or principal investigator(s):
James Lowder, MD, Principal Investigator, Affiliation: Prometheus Laboratories

Overall contact:
Theresa Luna, Phone: 858-882-8058, Email: tluna@prometheuslabs.com


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.

Clinical Details

Official title: Proleukin Observational Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy

Study design: Time Perspective: Prospective

Primary outcome: 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.

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Theresa Luna, Phone: 858-882-8058, Email: tluna@prometheuslabs.com

The University of Arizona Cancer Center, Tuscon, Arizona 85742, United States; Recruiting
Phone: 520-626-2010
Joanne Jeter, MD, Principal Investigator

Moores UCSD Cancer Center, La Jolla, California 92093, United States; Recruiting
Phone: 858-534-3804
Gregory Daniels, MD, Principal Investigator

USC Norris Cancer Center, Los Angeles, California 90089, United States; Recruiting
Phone: 323-865-0802
Michael Wong, MD, PhD, FRCPC, Principal Investigator

University of Colorado Cancer Center, Aurora, Colorado 80045, United States; Recruiting
Phone: 720-848-0564
Rene Gonzalez, MD, Principal Investigator

Mount Sinai Medical Center Comprehensive Cancer Center, Miami Beach, Florida 33140, United States; Recruiting
Phone: 305-674-2625
Jose Lutzky, MD, Principal Investigator

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida 33612, United States; Recruiting
Phone: 813-745-3982
Mayer Fishman, MD, PhD, Principal Investigator

Emory University Winship Cancer Institute, Atlanta, Georgia 30322, United States; Recruiting
Phone: 404-778-5680
David Lawson, MD, Principal Investigator

Rush Pres St Lukes Medical Center, Chicago, Illinois 60612, United States; Completed

Loyola University Medical Center, Maywood, Illinois 60153, United States; Recruiting
Phone: 708-327-3221
Joseph Clark, MD, Principal Investigator

Oncology Specialists, SC, Park Ridge, Illinois 60068, United States; Recruiting
Phone: 847-268-8574
Sigrun Hallmeyer, MD, Principal Investigator

Indiana University Melvin and Bren Simon Center, Indianapolis, Indiana 46202, United States; Recruiting
Phone: 317-948-7576
Theodore Logan, MD, Principal Investigator

University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, United States; Recruiting
Phone: 319-353-8775
Mohammed Milhem, MB, BS, Principal Investigator

University of Kansas Hospital, Kansas City, Kansas 66160, United States; Recruiting
Phone: 913-588-4709
Peter Van Veldhuizen, MD, Principal Investigator

The Baton Rouge Clinic, AMC, Baton Rouge, Louisiana 70808, United States; Recruiting
Phone: 225-767-0822
Gerald Miletello, MD, Principal Investigator

Johns Hopkins, Lutherville, Maryland 21093, United States; Recruiting
Phone: 410-583-2983
William Sharfman, MD, Principal Investigator

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States; Recruiting
Phone: 617-632-9270
David McDermott, MD, Principal Investigator

University of Michigan Health System, Ann Arbor, Michigan 48109, United States; Recruiting
Phone: 734-936-0467
Christopher Lao, MD, Principal Investigator

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201, United States; Recruiting
Phone: 313-576-8495
Ulka Vaishampayan, MD, Principal Investigator

University of Minnesota Masonic Cancer Center, Minneapolis, Minnesota 55455, United States; Recruiting
Phone: 612-626-3254
Venkatesh Rudrapatna, MD, Principal Investigator

Saint Louis University Cancer Cener, St. Louis, Missouri 63110, United States; Recruiting
Phone: 314-268-7059
John Richart, MD, Principal Investigator

Midwest Cancer Center - Legacy, Omaha, Nebraska 68130, United States; Recruiting
Phone: 402-691-6971
Ralph Hauke, MD, Principal Investigator

Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States; Recruiting
Phone: 603-650-4035
Marc Ernstoff, MD, Principal Investigator

Hackensack University Medical Center, Hackensack, New Jersey 07601, United States; Recruiting
Phone: 551-996-5900
Robert Alter, MD, Principal Investigator

Columbia University/Herbert Irving Comprehensive Cancer Center, New York, New York 10032, United States; Recruiting
Phone: 212-305-1317
Bret Taback, MD, Principal Investigator

Saint Luke's-Roosevelt Hospital Center, New York, New York 10019, United States; Recruiting
Phone: 212-523-7289
Seth Cohen, MD, Principal Investigator

Blumenthal Cancer Center, Charlotte, North Carolina 28203, United States; Recruiting
Phone: 704-355-5407
Asim Amin, MD, Principal Investigator

Duke University Medical Center, Durham, North Carolina 27705, United States; Recruiting
Phone: 919-684-6044
Michael Morse, MD, Principal Investigator

Wake Forest University Baptist Medical Center, Winston Salem, North Carolina 27157, United States; Recruiting
Phone: 336-713-6776
John Stewart IV, MD, Principal Investigator

The Christ Hospital Cancer Center, Cincinnati, Ohio 45219, United States; Recruiting
Phone: 513-585-0844
Philip Leming, MD, Principal Investigator

University Hospitals Siedman Cancer Center, Cleveland, Ohio 44106, United States; Recruiting
Phone: 216-844-1147
Henry Koon, MD, Principal Investigator

Providence Portland Medical Center, Portland, Oregon 97213, United States; Recruiting
Phone: 503-215-9948
Brendan Curti, MD, Principal Investigator

Saint Luke's Hospital and Health Network, Bethlehem, Pennsylvania 18015, United States; Recruiting
Phone: 484-503-4151
Sanjiv Agarwala, MD, Principal Investigator

Hillman Cancer Research Pavilion, Div. of Medical Oncology, Pittsburgh, Pennsylvania 15232, United States; Recruiting
Phone: 412-623-6121
John Kirkwood, MD, Principal Investigator

MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting
Phone: 713-792-7641
Sapna Patel, BA, MD, Principal Investigator

Huntsman Cancer Institute, Salt Lake City, Utah 84132, United States; Recruiting
Phone: 801-213-2780
Neeraj Agarwal, MD, Principal Investigator

Wheaton Franciscan Cancer Care, Franklin, Wisconsin 53132, United States; Recruiting
Phone: 414-427-2396
Jonathan Triesman, MD, Principal Investigator

Additional Information

Starting date: August 2011
Last updated: May 28, 2014

Page last updated: August 23, 2015

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