NCT01986712

Brief Summary

To evaluate the compliance with and perceptions of treatment, as well as health-related quality of life (HRQOL) in surgically resected melanoma patients undergoing HDI or PEG IFN therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2013

Longer than P75 for all trials

Geographic Reach
1 country

4 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

First Submitted

Initial submission to the registry

October 23, 2013

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 18, 2013

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2019

Completed
5.4 years until next milestone

Results Posted

Study results publicly available

February 13, 2025

Completed
Last Updated

February 13, 2025

Status Verified

January 1, 2025

Enrollment Period

4.6 years

First QC Date

October 23, 2013

Results QC Date

July 24, 2023

Last Update Submit

January 23, 2025

Conditions

Melanoma

Keywords

Melanoma, Stage III, adjuvant, Quality of Life

Outcome Measures

Primary Outcomes (1)

  • Evaluate Compliance With Standard High Dose Interferon (HDI) Versus Sylatron

    To evaluate compliance with administration of standard HDI versus PEG IFN for patients with surgically resected melanoma in need of adjuvant therapy

    1 year

Secondary Outcomes (4)

  • Compare Quality of Life (Qol)for Patients on HDI Versus PEG IFN

    baseline -week 1, week 3, week 13, week 25, week 50

  • Assess the Frequency of Grade 3 and Grade 4 Toxicities

    baseline-week 1, week 3, week 13, week 25, week 50

  • Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN

    baseline-week 1, week 3, week 13, week 25, week 50

  • Treatment-Related Side Effects Impacting Health-Related Quality of Life (FACT-BRM)

    Baseline-week 1, Week 3, week 13 week 25, week 50

Study Arms (2)

Intron A, HDI

High-dose interferon alfa (Intron A, HDI)

Sylatron

Pegylated alfa-interferon 2b (Sylatron, PEG IFN)

Eligibility Criteria

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

Patients with surgically resected melanoma receiving adjuvant therapy with HDI or PEG IFN thherapy

You may qualify if:

  • Patient is male or female at least 18 years of age
  • Patient has had surgically resected melanoma and plans to receive adjuvant therapy with HDI or PEG IFN
  • Patient is willing and able to give written informed consent
  • Patient is willing to comply with all study requirements

You may not qualify if:

  • Patient is unable or unwilling to complete QoL questionaire or compliance diary
  • Patient has a history of anaphylaxis due to any interferon alpha product
  • Patient has autoimmune hepatitis
  • Patient has decompensated liver disease (Child-Pugh score\>6 ( Class B and C)
  • Patient has a history of neuropsychiatric disorder (including depression) that, in the judgment of the investigator, may impair the patient's ability to successfully complete treatment or protocol-related requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Moffit Cancer Center

Tampa, Florida, 33612, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

St Luke's University Hospital and Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112-5550, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Neil Belman
Organization
St. Luke's University Health Network
neil.belman@sluhn.org
484-503-4673

Study Officials

  • Neil Belman, DO

    St. Luke's Hospital and Health Network, Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Neil Belman

Study Record Dates

First Submitted

October 23, 2013

First Posted

November 18, 2013

Study Start

December 1, 2013

Primary Completion

July 18, 2018

Study Completion

September 17, 2019

Last Updated

February 13, 2025

Results First Posted

February 13, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Locations

US(4)