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

This study has been completed.
Sponsor:
Collaborator:
Dermatologic Cooperative Oncology Group
Information provided by:
University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT00623402
First received: February 1, 2008
Last updated: January 11, 2011
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Melanoma
Drug: Sorafenib
Drug: pegylated interferon α-2b
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Treatment of Sorafenib and Pegylated Interferon α2b in Stage IV Metastatic Melanoma: a Prospective Non-randomized, Multicenter Phase II Study

Resource links provided by NLM:


Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • disease control rate (CR,PR,SD) [ Time Frame: 8 week staging ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Best response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Progression free survival (PFS) [ Time Frame: During active treatment ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 48 week follow-up ] [ Designated as safety issue: No ]
  • Safety and tolerability of the combined treatment [ Time Frame: During active treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 55
Study Start Date: January 2008
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Sorafenib
2x 400 mg orally per day (4 tablets)
Other Name: Sorafenib
Drug: pegylated interferon α-2b
3 µg/kg body weight s.c. once a week
Other Name: PegIntron

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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623402

Locations
Germany
Dpt. of Dermatology, Humboldt University
Berlin, Germany, 10117
Dept. of Dermatology, Elbe Klinikum
Buxtehude, Germany, 21614
Dpt. of Dermatology, University of Hannover
Hannover, Germany, 30449
Dpt. of Dermatology, University of Homburg/Saar
Homburg/Saar, Germany, 66421
Dpt. of Dermatology; UK-SH Campus Kiel, Germany
Kiel, Germany, D-24105
Dpt. of Dermatology, University of Cologne
Koeln, Germany, D-50937
Dpt. of Dermatology, University of Mannheim
Mannheim, Germany, 68163
Dpt. of Dermatology, Ludwig-Maximilian-University
München, Germany, 80337
Dpt. of Dermatology, University of Tübingen
Tübingen, Germany, 72076
Dpt. of Dermatology, University of Würzburg
Würzburg, Germany, 97080
Sponsors and Collaborators
University of Schleswig-Holstein
Dermatologic Cooperative Oncology Group
Investigators
Study Director: Axel Hauschild, MD UK-SH Department of Dermatology
  More Information

Additional Information:
No publications provided

Responsible Party: Axel Hauschild, MD, University Hospital Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT00623402     History of Changes
Other Study ID Numbers: DeCOG SoraPeg 2007, EudraCT 2007-001918-16
Study First Received: February 1, 2008
Last Updated: January 11, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Schleswig-Holstein:
Metastatic melanoma
Pegylated interferon
Protein Kinase Inhibitors
Sorafenib
PegIntron
Therapeutic Uses
melanoma (skin)

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Sorafenib
Interferons
Peginterferon alfa-2b
Protein Kinase Inhibitors
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014