A Study of Pegylated Interferon Alfa-2b as an Adjuvant Treatment in Japanese Patients With Malignant Melanoma (P08556)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01636960
First received: July 5, 2012
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

This is a study to evaluate the safety and tolerability of peginterferon alfa-2b (PegIFN alfa-2b) as adjuvant treatment in Japanese participants with malignant melanoma after definitive surgical resection including complete lymphadenectomy. Participants on this study will initially receive PegIFN alfa-2b for 8 weeks (Induction Phase) and then may continue to receive PegIFN alfa-2b (Maintenance Phase) as long as they are experiencing clinical benefit.


Condition Intervention Phase
Malignant Melanoma
Drug: PegIFN alfa-2b
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Single-arm, Multicenter Phase I Study of SCH 54031 (Pegylated Interferon Alfa-2b) as an Adjuvant Treatment in Japanese Patients With Malignant Melanoma (Protocol No. MK-4031 370 Also Known as SCH 54031, P08556)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Safety: Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Induction (From first dose through 8 weeks) ] [ Designated as safety issue: Yes ]
  • Tolerability: Incidence of dose-limiting toxicities (DLTs) [ Time Frame: Induction (From first dose through 8 weeks) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 9
Study Start Date: December 2012
Estimated Study Completion Date: October 2016
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Participants receiving PegIFN alfa-2b Drug: PegIFN alfa-2b
PegIFN alfa-2b, subcutaneously, on Day 1 of each week at a dose of 3 or 6 μg/kg for 8 weeks (induction) and 3 μg/kg for up to an additional 252 weeks (maintenance).

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage II or III melanoma
  • Primary melanoma completely excised
  • Full lymphadenectomy within 84 days prior to initiation of study treatment
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

  • Ocular melanoma or melanoma of the mucous membranes
  • Evidence of distant or non-regional lymph node metastases
  • In-transit melanoma
  • Previously treated with interferon alpha/beta, chemotherapy, hormonal therapy, radiotherapy or immunotherapy/vaccine for melanoma
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01636960     History of Changes
Other Study ID Numbers: P08556, MK-4031-370, 132228
Study First Received: July 5, 2012
Last Updated: April 29, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Peginterferon alfa-2b
Reaferon
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Adjuvants, Immunologic
Alcohol Deterrents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 09, 2014