NCT00623402

Brief Summary

To evaluate the efficacy and safety of a combined treatment with Sorafenib (Nexavar®) and pegylated interferon-α-2b (PegIntron®) in patients with malignant melanoma in stage IV.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

10 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

January 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2008

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 26, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Last Updated

January 12, 2011

Status Verified

February 1, 2008

Enrollment Period

1.8 years

First QC Date

February 1, 2008

Last Update Submit

January 11, 2011

Conditions

Melanoma

Keywords

Metastatic melanomaPegylated interferonProtein Kinase InhibitorsSorafenibPegIntronTherapeutic Usesmelanoma (skin)

Outcome Measures

Primary Outcomes (1)

  • disease control rate (CR,PR,SD)

    8 week staging

Secondary Outcomes (4)

  • Best response

    12 months

  • Progression free survival (PFS)

    During active treatment

  • Overall survival

    48 week follow-up

  • Safety and tolerability of the combined treatment

    During active treatment

Study Arms (1)

A

EXPERIMENTAL
Drug: SorafenibDrug: pegylated interferon α-2b

Interventions

SorafenibDRUG

2x 400 mg orally per day (4 tablets)

A
pegylated interferon α-2bDRUG

3 µg/kg body weight s.c. once a week

Also known as: PegIntron
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically documented metastatic melanoma classified as stage IV (AJCC 2002) of cutaneous origin.
  • ≥ 18 years of age
  • ECOG performance status of 0 or 1
  • Patients should not have received any systemic treatment for stage IV disease (study = "first-line" treatment).
  • Patients with progressive disease (PD) to stage IV under prior treatment with interferons as well as all patients who have already been treated with Sorafenib should not be included.
  • The following are allowed:
  • adjuvant interferon treatment (without progressive disease during treatment!) or vaccine therapy for resected stage I-III disease
  • palliative surgery or radiotherapy for stage IV disease
  • prior cytokine or chemotherapy treatment for local-regional disease by isolated limb perfusion or intralesional therapy
  • Life expectancy \>6 months.
  • Patients must have measurable disease defined as \>= 1 not pretreated unidimensional measurable lesion \>= 20 mm (conventional techniques) or \>= 10 mm by spiral CT/MRI.
  • absolute neutrophil count (ANC) \> 1.5 x 109/l
  • platelet count \> 100 x 109/l
  • hemoglobin \> 10 g/dl (\> 6.2 mmol/l)
  • serum creatinine \<= 1.5 x upper limit of institutional values
  • +8 more criteria

You may not qualify if:

  • Ocular or mucosal melanoma.
  • History or evidence of brain metastasis.
  • Patients with LDH values higher than 2x upper limit of institutional values.
  • Patients with thyroid dysfunctions not responsive to therapy.
  • Patients with uncontrolled diabetes mellitus.
  • Patients with prior or active autoimmune disease or autoimmune hepatitis.
  • Cardiac disease: congestive heart failure \> class II NYHA, patients must not have unstable angina or new onset of angina or myocardial infarction within the past 6 months. Cardiac ventricular arrhythmias requiring antiarrhythmic therapy.
  • Uncontrolled hypertension defined as systolic blood pressure \> 150 mm Hg or diastolic pressure \> 90 mm Hg, despite optimal management.
  • Active clinically serious infections \> CTCAE Grade 2.
  • Patients who are HIV positive or have AIDS.
  • Thrombotic or embolic events including transient ischemic attacks within the past 6 months.
  • Evidence or history of bleeding diathesis or coagulopathy.
  • Therapeutic anticoagulation with Vitamin K antagonists such as warfarin, or with heparins or heparinoids. Low dose warfarin is permitted if INR is \< 1.5. Low dose aspirin is permitted.
  • Known or suspected allergy to Sorafenib or any ingredient of Sorafenib or PEG-IFN-α -2b or any ingredient of PEG-IFN-α -2b or to any interferone.
  • Previous cancer that is distinct in primary site or histology from melanoma except cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors or any cancer curatively treated 3 years prior to study entry.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Dpt. of Dermatology, Humboldt University

Berlin, 10117, Germany

Location

Dept. of Dermatology, Elbe Klinikum

Buxtehude, 21614, Germany

Location

Dpt. of Dermatology, University of Cologne

Cologne, D-50937, Germany

Location

Dpt. of Dermatology, University of Hannover

Hanover, 30449, Germany

Location

Dpt. of Dermatology, University of Homburg/Saar

Homburg/Saar, 66421, Germany

Location

Dpt. of Dermatology; UK-SH Campus Kiel, Germany

Kiel, D-24105, Germany

Location

Dpt. of Dermatology, University of Mannheim

Mannheim, 68163, Germany

Location

Dpt. of Dermatology, Ludwig-Maximilian-University

München, 80337, Germany

Location

Dpt. of Dermatology, University of Tübingen

Tübingen, 72076, Germany

Location

Dpt. of Dermatology, University of Würzburg

Würzburg, 97080, Germany

Location

Related Links

MeSH Terms

Conditions

Melanoma

Interventions

Sorafenibpeginterferon alfa-2b

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)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Axel Hauschild, MD

    UK-SH Department of Dermatology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 1, 2008

First Posted

February 26, 2008

Study Start

January 1, 2008

Primary Completion

October 1, 2009

Last Updated

January 12, 2011

Record last verified: 2008-02

Locations

DE(10)