Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

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

Lead Sponsor:

University Hospital Schleswig-Holstein

Collaborating Sponsors:

Dermatologic Cooperative Oncology Group

Conditions:

Melanoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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.

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 p...

Eligibility Criteria

Inclusion

  • 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.
  • 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

Exclusion

  • 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.
  • 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.

Key Trial Info

Start Date :

January 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

55 Patients enrolled

Trial Details

Trial ID

NCT00623402

Start Date

January 1 2008

Last Update

January 12 2011

Active Locations (10)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (10 locations)

1

Dpt. of Dermatology, Humboldt University

Berlin, Germany, 10117

2

Dept. of Dermatology, Elbe Klinikum

Buxtehude, Germany, 21614

3

Dpt. of Dermatology, University of Cologne

Cologne, Germany, D-50937

4

Dpt. of Dermatology, University of Hannover

Hanover, Germany, 30449