Pegylated Interferon-alpha-2a in Patients With Malignant Melanoma Stage IIA-IIIB

Melanoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00204529
• Other study ID #: ML17840
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: May 2, 2017
• Start date: October 2004
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 901
• Est. completion date: December 2016
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• pegylated interferon-alpha-2a

• interferon-alpha-2a

Locations

Country	Name	City	State
Germany	Arbeitsgemeinschaft Dermatologische Onkologie, Skin Cancer Program, Department of Dermatology, University of Tübingen	Tübingen	BW

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Dermatologic Cooperative Oncology Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to distant metastasis		From date of randomization until the date of first documented distant metastases or date of death from any cause, whichever came first, assessed up to 60 months
Secondary	Disease free survival		5 years
Secondary	Overall survival		5 years
Secondary	Quality of life		Measured at different visits (week 0, week 12, month 3, month 6)
Secondary	Number and Grade of Adverse Events		Measured at every visit (week 4, week 8, week 12, month 3, month 6 and every 3 months during therapy)

External Links

•   Synopsis of study protocol