NCT01415167

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,690

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 for all trials

Geographic Reach
1 country

45 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

June 13, 2019

Status Verified

June 1, 2019

Enrollment Period

6.7 years

First QC Date

August 9, 2011

Last Update Submit

June 11, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients starting high dose IL-2 or Proleukin therapy are eligible to participate

You may qualify if:

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

You may not qualify if:

  • Prior high dose IL-2 or Proleukin therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (45)

The University of Arizona Cancer Center

Tucson, Arizona, 85742, United States

Location

Moores UCSD Cancer Center

La Jolla, California, 92093, United States

Location

USC Norris Cancer Center

Los Angeles, California, 90089, United States

Location

Southern California Permanente Medical Group

Riverside, California, 92505, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Mount Sinai Medical Center Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

University of Hawaii

Honolulu, Hawaii, 96822, United States

Location

Rush Pres St Lukes Medical Center

Chicago, Illinois, 60612, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Oncology Specialists, SC

Park Ridge, Illinois, 60068, United States

Location

Indiana University Melvin and Bren Simon Center

Indianapolis, Indiana, 46202, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

The Baton Rouge Clinic, AMC

Baton Rouge, Louisiana, 70808, United States

Location

Johns Hopkins

Lutherville, Maryland, 21093, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Saint Louis University Cancer Center

St Louis, Missouri, 63110, United States

Location

Midwest Cancer Center - Legacy

Omaha, Nebraska, 68130, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Saint Luke's-Roosevelt Hospital Center

New York, New York, 10019, United States

Location

Columbia University/Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

The Research Foundation for The State University of New York

Syracuse, New York, 13210, United States

Location

Blumenthal Cancer Center

Charlotte, North Carolina, 28203, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

The Christ Hospital Cancer Center

Cincinnati, Ohio, 45219, United States

Location

University of Cincinnati Cancer Institute

Cincinnati, Ohio, 45267, United States

Location

University Hospitals Siedman Cancer Center

Cleveland, Ohio, 44106, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Saint Luke's Hospital and Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

The Pennsylvania State University and The Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Hillman Cancer Research Pavilion, Div. of Medical Oncology

Pittsburgh, Pennsylvania, 15232, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84132, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Wheaton Franciscan Cancer Care

Franklin, Wisconsin, 53132, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Carcinoma, Renal CellMelanoma

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Michael Wong, MD

    MD Anderson

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2011

First Posted

August 11, 2011

Study Start

August 1, 2011

Primary Completion

April 1, 2018

Study Completion

May 1, 2018

Last Updated

June 13, 2019

Record last verified: 2019-06

Locations