Pegylated Interferon-alpha-2a in Patients With Malignant Melanoma Stage IIA-IIIB
This study is ongoing, but not recruiting participants.
Sponsor:
University Hospital Tuebingen
Collaborator:
Dermatologic Cooperative Oncology Group
Information provided by (Responsible Party):
Thomas Eigentler, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00204529
First received: September 12, 2005
Last updated: January 15, 2013
Last verified: January 2013
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Purpose
The purpose of this study is to evaluate the efficacy and safety of adjuvant treatment with pegylated interferon-α-2a (PEG-IFN) vs. 'low dose' interferon-α-2a in patients with malignant melanoma in stage IIA (T3a) - IIIB.
A total of 880 will be randomized up to three months after first surgical management of their melanoma to either: PEG-IFN-α-2a or low-dose interferon-α-2a.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma |
Drug: pegylated interferon-alpha-2a Drug: interferon-alpha-2a |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized, Multicenter, Open Label Study to Compare the Efficacy and Tolerability of Pegylated Interferon-alpha-2 (PEG-IFN) to 'Low-dose' Interferon-alpha-2a in Patients With Malignant Melanoma in Stages IIA (T3a) - IIIB (AJCC 2002) |
Resource links provided by NLM:
Further study details as provided by University Hospital Tuebingen:
Primary Outcome Measures:
- Time to distant metastasis
Secondary Outcome Measures:
- Disease free survival at 5 years
- Overall survival at 5 years
- Quality of life
- Tolerability
| Estimated Enrollment: | 880 |
| Study Start Date: | October 2004 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PegIFN
pegylated interferon-alpha-2a
|
Drug: pegylated interferon-alpha-2a |
|
Active Comparator: IFN
interferon-alpha-2a
|
Drug: interferon-alpha-2a |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically proven cutaneous melanoma
- ≥ 18 years of age and < 75 years of age
- Have confirmed stage IIa (T3a), IIB, IIC, IIIA or IIIB (AJCC 2002) melanoma (lymph node staging either per sentinel node biopsy or elective lymph node dissection)
- Have a Karnofsky performance status of ≥ 80%
- Negative pregnancy test
- Start of therapy within three months after surgery
- Informed consent
Exclusion Criteria:
- Pregnant or lactating women
- Unwillingness or inability to employ an effective barrier method of birth control throughout the study and for up to 3 months after end of treatment in female or male patients
- Mucous membrane or ocular melanoma
- Any evidence of distant metastasis (CT-scan of brain, Chest X ray or CT, abdominal ultrasound or CT and ultrasound of regional lymph nodes at screening)
- Patients who have received chemotherapy or vaccines for melanoma
- Patients with tumor progression under a previous adjuvant interferon therapy or within three months after termination of interferon therapy (patients previously receiving adjuvant interferon therapy in another tumor stage without disease progression may be included)
- History of any other malignancy within the last ten years (except basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix)
- Patients with severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina), severe liver disease or severe renal disease.
- ALAT or ASAT > 2 x ULN
- Bilirubin > 2 x ULN
- Creatinine > 2 x ULN
- Patients who have a history of depression or other psychiatric diseases requiring hospitalisation
- Patients with seizure disorders requiring anticonvulsant therapy
Any of the following abnormal baseline hematologic/laboratory values:
- Hb <10g/dl
- WBC <3.0 x 109 /l
- Platelets <100x109/l
- Neutrophils < 1.5 x 109/l
- History or presence of autoimmune disease (i.e. autoimmune hepatitis, thyroid auto-immune dysfunction, systemic lupus erythematodes)
- Unwilling or unable to comply with the requirements of the protocol for the duration of the study
- Known infection with HBV, HCV, HIV
- Evidence of allergy or hypersensitivity against IFN or pegylated interferon
- Thyroid disease poorly controlled on prescribed medications
- Systemic corticosteroid therapy for any reason (>1 month)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204529
Locations
| Germany | |
| Arbeitsgemeinschaft Dermatologische Onkologie, Skin Cancer Program, Department of Dermatology, University of Tübingen | |
| Tübingen, BW, Germany, 72076 | |
Sponsors and Collaborators
University Hospital Tuebingen
Dermatologic Cooperative Oncology Group
Investigators
| Principal Investigator: | Claus Garbe, MD | Skin Cancer Program, Department of Dermatology, University of Tübingen, Liebermeisterstr. 20, 72076 Tübingen, Germany |
| Principal Investigator: | Hubert Pehamberger, MD | Department of Dermatology, University Hospital Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria |
More Information
Additional Information:
No publications provided
| Responsible Party: | Thomas Eigentler, MD, University Hospital Tuebingen |
| ClinicalTrials.gov Identifier: | NCT00204529 History of Changes |
| Other Study ID Numbers: | ML17840 |
| Study First Received: | September 12, 2005 |
| Last Updated: | January 15, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University Hospital Tuebingen:
|
malignant melanoma adjuvant therapy Adjuvants, Immunologic |
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 Adjuvants, Immunologic Interferon-alpha Interferon Alfa-2a Interferons |
Peginterferon alfa-2a Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antiviral Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 21, 2013