NCT00749684

Brief Summary

The aim of this observational study is to document the efficacy and tolerability of high-dose interferon therapy in adult participants with malignant melanoma at high risk of relapse and to compare them with the survival times and relapse rates in previous studies (historical control).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 1996

Longer than P75 for all trials

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

December 1, 1996

Completed
11.8 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 24, 2011

Completed
Last Updated

October 19, 2015

Status Verified

October 1, 2015

Enrollment Period

12.8 years

First QC Date

September 8, 2008

Results QC Date

October 22, 2010

Last Update Submit

October 16, 2015

Conditions

Melanoma

Keywords

interferon-alpha

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Disease Recurrence

    Number of participants with disease recurrence was being measured.

    Throughout 12 months of treatment and 24 months of follow-up

  • Relapse Free Survival Time

    Median time to recurrence according to Kaplan Maier evaluation

    Throughout 12 months of treatment and 24 months of follow-up

Study Arms (1)

Adults with malignant melanoma at high risk of relapse

Adults with malignant melanoma of the following stages: * II and III (\>/= 1.5 mm Breslow thickness without distant metastases * melanoma with lymph node metastases

Biological: Interferon α-2b

Interventions

Interferon α-2bBIOLOGICAL

20 mio IU/m² interferon-α-2b 5x/week intravenously (IV) over the course of 1 month, followed by 10 mio IU/m² interferon-α-2b 3x/week subcutaneously (SC) for 11 months.

Also known as: Intron A
Adults with malignant melanoma at high risk of relapse

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult participants in Austria with malignant melanoma at high risk of relapse

You may qualify if:

  • Male and female participants
  • Age 18-70 years
  • Malignant melanoma stage II or III (\>/= 1.5 mm tumor thickness, no distant metastases or Malignant melanoma with lymph node metastases or Lymph node metastases with unknown primary tumor
  • An excision border of at least 2 cm around the primary tumor
  • Therapy must start within 12 weeks after surgery of the tumor/of the lymph node metastases
  • ECOG status 0-1 (= Karnofsky Index \>/= 80)
  • Laboratory parameters
  • Hematocrit \>= 33%
  • Leukocytes \>= 3000/μl
  • Thrombocytes \>= 100000/μl
  • Alanine aminotransferase(ALT) \<= 2x normal values
  • Bilirubin \<= 2x normal values

You may not qualify if:

  • Known allergy to one of the medications or any of its component parts
  • Refusal on the part of participants capable of childbearing to use a reliable contraceptive
  • Lactating mothers
  • Presence of distant metastases
  • Another primary tumor of different histological origin than corresponding to the indication (except when the relapse-free interval is \> 5 years, or the tumor is a cervical carcinoma in situ, a basal cell carcinoma or cutaneous squamous cell carcinoma)
  • Participants on corticosteroid treatment or treatment with an immunomodulating substance
  • Preexisting psychiatric illness, particularly serious depression
  • Prior adjuvant radio-, chemo-, or immuno-therapy
  • Treatment with an investigational drug within the prior 30 days
  • Participant history that includes cardiac arrhythmia, cardiac insufficiency requiring treatment, or anthracycline administration
  • Myocardial infarction within the prior year
  • An unstable medical condition (apart from the indication) that in the judgment of the investigating physician excludes the participants from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Melanoma

Interventions

Introns

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

Intervention Hierarchy (Ancestors)

DNA, IntergenicGenome ComponentsGenomeGenetic StructuresGenetic PhenomenaGene ComponentsGenes

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp and Dohme Corp.
clinicaltrialsdisclosure@merck.com
1-800-672-6372

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

September 8, 2008

First Posted

September 9, 2008

Study Start

December 1, 1996

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

October 19, 2015

Results First Posted

March 24, 2011

Record last verified: 2015-10