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

Melanoma Clinical Trial

Official title:

Efficacy and Safety of High-dose Treatment With the Immunomodulator Interferon-α-2b (Intron A®) for the Adjuvant Treatment of Malignant Melanoma.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749684
• Other study ID #: P04083
• Status: Completed
• Phase: N/A
• First received: September 8, 2008
• Last updated: October 16, 2015
• Start date: December 1996
• Est. completion date: September 2009

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Melanoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Disease Recurrence	Number of participants with disease recurrence was being measured.	Throughout 12 months of treatment and 24 months of follow-up	No
Primary	Relapse Free Survival Time	Median time to recurrence according to Kaplan Maier evaluation	Throughout 12 months of treatment and 24 months of follow-up	No