Efficacy and Safety of High-dose Interferon Alfa-2b (Intron A®) for the Adjuvant Treatment of Malignant Melanoma (Study P04083)

NCT ID: NCT00749684

Last Updated: 2015-10-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 138 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1996-12-31
• Study Completion Date: 2009-09-30

Brief Summary

The aim of this observational study is to document the efficacy and tolerability of high-dose interferon therapy in adult participants with malignant melanoma at high risk of relapse and to compare them with the survival times and relapse rates in previous studies (historical control).

Detailed Description

Observational study to evaluate the tolerability and efficacy (vs historical controls) of a high-dose therapy scheme with interferon-α-2b (IntronA®):

Adjuvant treatment with interferon-α-2 has been demonstrated in a number of studies to have an antiproliferative effect on malignant melanoma. In these cases a response rate of up to 20% could be achieved with a dose of 10 million IU or more 3x/week or daily. Kirkwood et al. showed in a study carried out in ECOG (the Eastern Cooperative Oncology Group, study no. 1684) that there was a clear and significant survival advantage versus the observation group with the following dose:

20 mio IU/m² interferon-α-2b (IntronA®) 5x/week iv over the course of one month followed by 11 months with 10 mio IU/m² 3x/week sc.

Conditions

Melanoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adults with malignant melanoma at high risk of relapse

Adults with malignant melanoma of the following stages:

• II and III (>/= 1.5 mm Breslow thickness without distant metastases
• melanoma with lymph node metastases

Interferon α-2b

Intervention Type: BIOLOGICAL

20 mio IU/m² interferon-α-2b 5x/week intravenously (IV) over the course of 1 month, followed by 10 mio IU/m² interferon-α-2b 3x/week subcutaneously (SC) for 11 months.

Interventions

Interferon α-2b

20 mio IU/m² interferon-α-2b 5x/week intravenously (IV) over the course of 1 month, followed by 10 mio IU/m² interferon-α-2b 3x/week subcutaneously (SC) for 11 months.

Intervention Type: BIOLOGICAL

Other Intervention Names

Intron A

Eligibility Criteria

Inclusion Criteria

• Male and female participants
• Age 18-70 years
• Malignant melanoma stage II or III (>/= 1.5 mm tumor thickness, no distant metastases or Malignant melanoma with lymph node metastases or Lymph node metastases with unknown primary tumor
• An excision border of at least 2 cm around the primary tumor
• Therapy must start within 12 weeks after surgery of the tumor/of the lymph node metastases
• ECOG status 0-1 (= Karnofsky Index >/= 80)
• Laboratory parameters

• Hematocrit >= 33%
• Leukocytes >= 3000/μl
• Thrombocytes >= 100000/μl
• Alanine aminotransferase(ALT) <= 2x normal values
• Bilirubin <= 2x normal values

Exclusion Criteria

• Known allergy to one of the medications or any of its component parts
• Refusal on the part of participants capable of childbearing to use a reliable contraceptive
• Lactating mothers
• Presence of distant metastases
• Another primary tumor of different histological origin than corresponding to the indication (except when the relapse-free interval is > 5 years, or the tumor is a cervical carcinoma in situ, a basal cell carcinoma or cutaneous squamous cell carcinoma)
• Participants on corticosteroid treatment or treatment with an immunomodulating substance
• Preexisting psychiatric illness, particularly serious depression
• Prior adjuvant radio-, chemo-, or immuno-therapy
• Treatment with an investigational drug within the prior 30 days
• Participant history that includes cardiac arrhythmia, cardiac insufficiency requiring treatment, or anthracycline administration
• Myocardial infarction within the prior year
• An unstable medical condition (apart from the indication) that in the judgment of the investigating physician excludes the participants from the study
• Psoriasis (a relative exclusion criterion, since interferon can aggravate psoriasis; decision to be based on risk/benefit analysis)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P04083

Identifier Type: -

Identifier Source: org_study_id