Pegylated Interferon-alpha-2a in Patients With Malignant Melanoma Stage IIA-IIIB

May 2, 2017 updated by: Thomas Eigentler, University Hospital Tuebingen

Randomized, Multicenter, Open Label Study to Compare the Efficacy and Tolerability of Pegylated Interferon-alpha-2 (PEG-IFN) to 'Low-dose' Interferon-alpha-2a in Patients With Malignant Melanoma in Stages IIA (T3a) - IIIB (AJCC 2002)

The purpose of this study is to evaluate the efficacy and safety of adjuvant treatment with pegylated interferon-α-2a (PEG-IFN) vs. 'low dose' interferon-α-2a in patients with malignant melanoma in stage IIA (T3a) - IIIB.

A total of 880 will be randomized up to three months after first surgical management of their melanoma to either: PEG-IFN-α-2a or low-dose interferon-α-2a.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

901

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • BW
      • Tübingen, BW, Germany, 72076
        • Arbeitsgemeinschaft Dermatologische Onkologie, Skin Cancer Program, Department of Dermatology, University of Tübingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically proven cutaneous melanoma
  • ≥ 18 years of age and < 75 years of age
  • Have confirmed stage IIa (T3a), IIB, IIC, IIIA or IIIB (AJCC 2002) melanoma (lymph node staging either per sentinel node biopsy or elective lymph node dissection)
  • Have a Karnofsky performance status of ≥ 80%
  • Negative pregnancy test
  • Start of therapy within three months after surgery
  • Informed consent

Exclusion Criteria:

  • Pregnant or lactating women
  • Unwillingness or inability to employ an effective barrier method of birth control throughout the study and for up to 3 months after end of treatment in female or male patients
  • Mucous membrane or ocular melanoma
  • Any evidence of distant metastasis (CT-scan of brain, Chest X ray or CT, abdominal ultrasound or CT and ultrasound of regional lymph nodes at screening)
  • Patients who have received chemotherapy or vaccines for melanoma
  • Patients with tumor progression under a previous adjuvant interferon therapy or within three months after termination of interferon therapy (patients previously receiving adjuvant interferon therapy in another tumor stage without disease progression may be included)
  • History of any other malignancy within the last ten years (except basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix)
  • Patients with severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina), severe liver disease or severe renal disease.
  • ALAT or ASAT > 2 x ULN
  • Bilirubin > 2 x ULN
  • Creatinine > 2 x ULN
  • Patients who have a history of depression or other psychiatric diseases requiring hospitalisation
  • Patients with seizure disorders requiring anticonvulsant therapy

  • Any of the following abnormal baseline hematologic/laboratory values:

    • Hb <10g/dl
    • WBC <3.0 x 109 /l
    • Platelets <100x109/l
    • Neutrophils < 1.5 x 109/l
  • History or presence of autoimmune disease (i.e. autoimmune hepatitis, thyroid auto-immune dysfunction, systemic lupus erythematodes)
  • Unwilling or unable to comply with the requirements of the protocol for the duration of the study
  • Known infection with HBV, HCV, HIV
  • Evidence of allergy or hypersensitivity against IFN or pegylated interferon
  • Thyroid disease poorly controlled on prescribed medications
  • Systemic corticosteroid therapy for any reason (>1 month)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PegIFN
pegylated interferon-alpha-2a
Drug: pegylated interferon-alpha-2a
Active Comparator: IFN
interferon-alpha-2a
Drug: interferon-alpha-2a

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to distant metastasis
Time Frame: From date of randomization until the date of first documented distant metastases or date of death from any cause, whichever came first, assessed up to 60 months
From date of randomization until the date of first documented distant metastases or date of death from any cause, whichever came first, assessed up to 60 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 5 years
5 years
Disease free survival
Time Frame: 5 years
5 years
Quality of life
Time Frame: Measured at different visits (week 0, week 12, month 3, month 6)
Measured at different visits (week 0, week 12, month 3, month 6)
Number and Grade of Adverse Events
Time Frame: Measured at every visit (week 4, week 8, week 12, month 3, month 6 and every 3 months during therapy)
Measured at every visit (week 4, week 8, week 12, month 3, month 6 and every 3 months during therapy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Collaborators

Dermatologic Cooperative Oncology Group

Investigators

  • Principal Investigator: Claus Garbe, MD, Skin Cancer Program, Department of Dermatology, University of Tübingen, Liebermeisterstr. 20, 72076 Tübingen, Germany
  • Principal Investigator: Hubert Pehamberger, MD, Department of Dermatology, University Hospital Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2004

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML17840

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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