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MelanomaPhase 2SoraPegNCT00623402

Combined Treatment of Sorafenib and Pegylated Interferon α2b in Stage IV Metastatic Melanoma

A Phase 2 study testing Sorafenib and pegylated interferon α-2b in people with Melanoma, run by University Hospital Schleswig-Holstein at 10 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
Sorafenib and pegylated interferon α-2b
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
10 sitesGermany
Study dates
Jan 2008to Oct 2009
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.
  • Patients must have adequate hematological, renal and liver functions as defined by laboratory values below performed within 14 days prior to study inclusion:
  • 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
  • total serum bilirubin <= 1.5x upper limit of institutional values
  • ALAT and ASAT <= 2.5x upper limit of institutional values (exception: liver metastases)
  • In addition:
  • Patients should not suffer from frequent vomiting or medical conditions which could interfere with oral medication intake.
  • Negative pregnancy test of women of childbearing potential performed within 7 days prior to the start of treatment.
  • Women of childbearing potential must agree to use an effective method of contraception (Pearl-Index < 1, e.g. hormonal contraception including the combined oral contraceptive pill, the transdermal patch, and the contraceptive vaginal ring, intrauterine devices or sterilization) during treatment and for at least 6 months thereafter.
  • Men must agree to use an effective method of contraception during treatment and for at least 6 months thereafter.
  • Patients should understand the informed consent and will need to sign the consent

Who cannot join

  • 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.
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  • 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.
  • Substance abuse, medical or psychological condition that may interfere with the patient´s participation in the study.
  • Patients with medication requiring chronic systemic corticosteroids.
  • Patients with prior systemic anticancer treatment in the last 2 weeks.
  • Patients with severe liver disease or severe renal disease.
  • Patients with seizure disorders requiring anticonvulsant therapy.
  • Patients with any severe debilitating diseases.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Germany10 sites

  • Dpt. of Dermatology, Humboldt University

    Berlin, 10117

  • Dept. of Dermatology, Elbe Klinikum

    Buxtehude, 21614

  • Dpt. of Dermatology, University of Cologne

    Cologne, D-50937

  • Dpt. of Dermatology, University of Hannover

    Hanover, 30449

  • Dpt. of Dermatology, University of Homburg/Saar

    Homburg/Saar, 66421

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

    Kiel, D-24105

  • Dpt. of Dermatology, University of Mannheim

    Mannheim, 68163

  • Dpt. of Dermatology, Ludwig-Maximilian-University

    München, 80337

  • Dpt. of Dermatology, University of Tübingen

    Tübingen, 72076

  • Dpt. of Dermatology, University of Würzburg

    Würzburg, 97080

Other trials in Germany

About this study

Official title: Combined Treatment of Sorafenib and Pegylated Interferon α2b in Stage IV Metastatic Melanoma: a Prospective Non-randomized, Multicenter Phase II Study

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.

Read the detailed description

This is a a prospective non-randomized, multicenter Phase II Study 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.

The investigators will determine disease control rate (CR,PR,SD) after 8 weeks of treatment with pegylated interferon- α-2b (3 µg/kg body weight s.c. once a week) combined with Sorafenib 2x 400 mg (2 tablets orally, twice daily)

Conditions
Melanoma
Being tested
Sorafenib, pegylated interferon α-2b
Keywords
Metastatic melanoma, Pegylated interferon, Protein Kinase Inhibitors, Sorafenib, PegIntron, Therapeutic Uses, melanoma (skin)
Medical subject headings
Melanoma

What participants receive

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

  • SorafenibDrug

    2x 400 mg orally per day (4 tablets)

  • pegylated interferon α-2bDrug

    Also called PegIntron

    3 µg/kg body weight s.c. once a week

Study groups in NCT00623402
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Drug: Sorafenib; Drug: pegylated interferon α-2b

What is being measured

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

  1. disease control rate (CR,PR,SD)

    Measured: 8 week staging

Secondary outcomes (4)

  1. Best response

    Measured: 12 months

  2. Progression free survival (PFS)

    Measured: During active treatment

  3. Overall survival

    Measured: 48 week follow-up

  4. Safety and tolerability of the combined treatment

    Measured: During active treatment

Timeline

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

  1. First posted26 Feb 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionOct 2009

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00623402
Sponsor's protocol ID
DeCOG SoraPeg 2007
Other IDs
EudraCT 2007-001918-16
Acronym
SoraPeg
Status last verified
Feb 2008
First submitted
1 Feb 2008
Last updated
12 Jan 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sorafenib and pegylated interferon α-2b in people with Melanoma, run by University Hospital Schleswig-Holstein at 10 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 24 inclusion and 21 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: finished, as of the sponsor's last update on 12 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

disease control rate (CR,PR,SD) (time frame: 8 week staging). 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 NCT00623402.

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 12 Jan 2011.

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