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

18 Years
Open (Enrolling)
Metastatic Renal Cell Carcinoma, Metastatic Melanoma

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Trial Information

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

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.

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

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome 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.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

James Lowder, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Prometheus Laboratories


United States: Institutional Review Board

Study ID:




Start Date:

August 2011

Completion Date:

August 2016

Related Keywords:

  • Metastatic Renal Cell Carcinoma
  • Metastatic Melanoma
  • Carcinoma
  • Carcinoma, Renal Cell
  • Melanoma



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Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Loyola University Medical CenterMaywood, Illinois  60153
Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Saint Luke's-Roosevelt Hospital CenterNew York, New York  10019
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Providence Portland Medical CenterPortland, Oregon  97213-3635
Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
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USC Norris Cancer CenterLos Angeles, California  90033
Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157
Rush Pres St Lukes Medical CenterChicago, Illinois  60612
Indiana University Melvin and Bren Simon CenterIndianapolis, Indiana  46202
Mount Sinai Medical Center Comprehensive Cancer CenterMiami Beach, Florida  33140
The Baton Rouge Clinic, AMCBaton Rouge, Louisiana  70808
University of Minnesota Masonic Cancer CenterMinneapolis, Minnesota  55455
Midwest Cancer Center - LegacyOmaha, Nebraska  68130
University Hospitals Siedman Cancer CenterCleveland, Ohio  44106
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