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AdjuvantPhase 3NCT00226408

Standard High-Dose Alpha Interferon Versus Intermittent High-Dose Alpha Interferon

A Phase 3 study testing Interferon-alpha-2b in people with Adjuvant and Stage III Malignant Melanoma, run by Dermatologic Cooperative Oncology Group at 13 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The study protocol is being conducted to compare intermittent high-dose i.v. administation of interferon alpha-2b with the standard high-dose treatment by Kirkwood with distant metastasis free survival (DMFI) as a primary endpoint. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Interferon-alpha-2b
How many people
600 participants
Where
13 sitesGermany
Study dates
Nov 2003to Sep 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological documentet cutaneous malognant melanoma
  • Stage IIIa, IIIb, IIIc (AJCC 2002)
  • R0 resection dating back no longer than 56 days
  • Performance status (ECOG o-1)
  • Bone marrow funktion: White cell count > 3000 cells/ul, platletts > 100000 cells/ul, hemoglobin > 10 g/dl
  • Liver and kidney funktion: Serum creatinin < 1.5 times upper limit of normal, AST and ALT < 2.5 times upper limit of normal, Serum bilirubin < 2 times upper limit of normal
  • Written inform consent

Who cannot join

  • Confirmed distant metastasis
  • Choroid or mucosal melanoma
  • Pregnant or lactating women and women of childbearing potential not using a reliable form of contraception
  • Active autoimmun disease
  • patients with history of neuropsychiatric disease requiring hospitalization
  • Severe medical condition such us:
Show all 16Show fewer
  • Florid hepatitis
  • Severe acute infection
  • Myocardial infarction within the past year,symptomatic angina pectoris
  • Grade III to IV congestive heart failure
  • serious pulmonary disease
  • HIV-positive patients with an AIDS - defining condition
  • treatment in another clinical drug trial within the last 30 days
  • A history of hypersensitivity to interferon alfa
  • History of maignant disease during the past 5 years (except for curatively treated skin carcinoma or in situ carcinoma)
  • Prior high dose interferon alfa therapy.Prior adjuvant low dose or intermediate-dose interferon alfa therapy is allowed

Trial locations and contacts

13 sites in 1 country.

Peter Mohr, MD contact

0049 41261 703 ext. 6207

p.mohr@elbekliniken.de

Michael Weichenthal, MD contact

0049 431 597 ext. 1537

mweichenthal@dermatology.uni-kiel.de

13 sites in 1 country

Germany13 sites, 13 recruiting

  • Universitätshautklinik ,St.Josef- Hospital

    Bochum, 44791

    Norbert Brockmeyer, MD, 0049/234 ext. 509-1

    Recruiting

  • Elbekliniken Buxtehude

    Buxtehude, 21614

    Peter Miohr, MD, 0049 4161 703 ext. 6207, p.mohr@elbekliniken.de

    michael weichenthal, MD, 0049 431 597 ext. 1537, mweichenthal@dermatolgy.uni-kiel.de

    Recruiting

  • Universitätshautklinik Köln

    Cologne, 50931

    Cornelia Mauch, MD, 0049/221478 ext. 537

    Recruiting

  • Universitätshautklinik Essen

    Essen, 45122

    Carmen Loquai, MD, 0049/201-723 ext. 243

    Recruiting

  • Universitätsklinik Eppendorf

    Hamburg, 20246

    Karsten Neuber, MD, 0049/42803 ext. 2632

    Recruiting

  • Praxis

    Hanover, 30159

    Peter von Wussow, MD, 0049/511 ext. 3069998

    Recruiting

  • Universitätshautklinik Heidelberg

    Heidelberg, 69115

    Alexander Enk, MD

    Recruiting

  • Universitätsklinikum des Saarlandes, Hautklinik

    Homburg/ Saar, 66421

    Wolfgang Tilgen, MD, 0049/6841-162 ext. 3966

    Recruiting

  • Christian- Albrechts- Universität ,Hautklinik

    Kiel, 24105

    Axel Hauschild, MD, 0049/431-597 ext. 15

    Recruiting

  • Universitätshautklinik Mainz

    Mainz, 55131

    Kerstin Steinbrink, MD, 0049/61311771 ext. 30

    Recruiting

  • universitätsklinikum Münster

    Münster, 48149

    T. Luger, MD, 0049/25183 ext. 56501

    Recruiting

  • Städtische Kliniken Oldenburg

    Oldenburg, 261333

    Erhard Hölzle, MD

    Recruiting

  • Universitätshautklinik Ulm

    Ulm, 89081

    Cord Sunderkötter, MD

    Recruiting

Other trials in Germany

About this study

Official title: Randomized, Multicenter Study for Adjuvant Treatment of Stage III Malignant Melanoma: Intermittent, High-Dose Intravenous Interferon Alpha-2b Versus Standard High-Dose Interferon Alpha-2b Therapy

The study protocol is being conducted to compare intermittent high-dose i.v. administation of interferon alpha-2b with the standard high-dose treatment by Kirkwood with distant metastasis free survival (DMFI) as a primary endpoint.

Read the detailed description

Arm A: Interferon-alpha-2b 20 MIU/m2 for 4 weeks. 5 days a week i.v followed by 48 weeks of treatment with 3 x 10 MIU/m2 s.c Arm B: Interferon-alpha-2b 20 MIU/m2 for 4 weeks. 5 days a week i.v repeated 3 times with 12 treatment-free-weeks between the cycles

Secondary endpoints: Improved overall survival rate, Assess side effects of therapy in both treatment arms, Assess time spent on sick leave, Assess number of treatment-related days in hospital, Assess overall performance status, Assess blood MX protein levels

Being tested
Interferon-alpha-2b
Keywords
melanoma,adjuvant therapy,stageIII Interferon, high dose
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interferon-alpha-2bDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. distant metastasis free survival/(DMFI )

Secondary outcomes (3)

  1. overall survival

  2. time to progression

  3. toxicity

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2005 (estimated)
  2. Study startNov 2003
  3. Study completionSep 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00226408
Sponsor's protocol ID
MM-ADJ-5
Status last verified
Sep 2005
First submitted
25 Sep 2005
Last updated
21 Jun 2006
Results posted
No

Publications

  • Mohr P, Hauschild A, Trefzer U, Enk A, Tilgen W, Loquai C, Gogas H, Haalck T, Koller J, Dummer R, Gutzmer R, Brockmeyer N, Holzle E, Sunderkotter C, Mauch C, Stein A, Schneider LA, Podda M, Goppner D, Schadendorf D, Weichenthal M. Intermittent High-Dose Intravenous Interferon Alfa-2b for Adjuvant Treatment of Stage III Melanoma: Final Analysis of a Randomized Phase III Dermatologic Cooperative Oncology Group Trial. J Clin Oncol. 2015 Dec 1;33(34):4077-84. doi: 10.1200/JCO.2014.59.6932. Epub 2015 Oct 26.

    PubMed 26503196

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Interferon-alpha-2b in people with Adjuvant and Stage III Malignant Melanoma, run by Dermatologic Cooperative Oncology Group at 13 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Peter Mohr, MD (0049 41261 703 ext. 6207, p.mohr@elbekliniken.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

distant metastasis free survival/(DMFI ). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00226408, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2006.

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