- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03552549
SCH 54031 PEG12000 Interferon Alfa-2b (PEG Intron, MK-4031) vs. INTRON®A (SCH 30500, MK-2958) as Adjuvant Therapy for Melanoma (C98-135, MK-4031-002)
July 16, 2019 updated by: Merck Sharp & Dohme LLC
A Randomized Phase II/III Trial of SCH 54031 PEG12000 Interferon Alfa-2b (PEG Intron) vs. INTRON®A as Adjuvant Therapy for Melanoma
This is a Phase II/III randomized, controlled, multicenter, open-label study designed to assess the safety, efficacy, and impact on quality of life of PEG Intron (MK-4031) and INTRON® A (MK-2958) and the pharmacokinetics of PEG Intron when given as adjuvant (after surgery) therapy in participants with resected (surgically removed) Stage III node-positive cutaneous melanoma.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
This study was closed to enrollment prematurely due to sub-optimal accrual.
Participants who were enrolled prior to enrollment closure were allowed to continue to receive study drug; these participants were followed for safety only.
Study Type
Interventional
Enrollment (Actual)
126
Phase
- Phase 2
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Participants must have histologically documented primary cutaneous melanoma meeting one of the following staging criteria:
- Primary melanoma of any stage in the presence of N1 regional lymph node metastases detected at elective lymph node dissection or sentinel node biopsy, with clinically inapparent regional lymph node metastasis (any pTN1M0).
- Clinically apparent N1 or N2a regional lymph node involvement synchronous with primary melanoma of T1-4 (any pTN1-2aM0).
- Regional lymph node recurrence at any interval after appropriate surgery for primary melanoma of any depth (any primary tumor [pT], r N1-2a M0).
- Participants must have had all known disease completely resected with adequate surgical margins within 56 days prior to randomization into the study
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Participants must have adequate hepatic, renal and bone marrow function as defined by the following parameters obtained within 14 days prior to initiation of study treatment:
- Hematology: white blood cells (WBC) ≥3,000 cells/µL and hemoglobin ≥9 g/dL.
- Renal and hepatic function: serum creatinine <2.0 mg/dL; aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) <2 times upper limit of laboratory normal (ULN); and serum bilirubin <2 times ULN
- Participants must sign and date a voluntary informed consent form before study entry, be willing to participate in this study and agree to complete all follow-up assessments.
Exclusion Criteria:
- Participants who have received any prior chemotherapy, immunotherapy hormonal or radiation therapy for melanoma.
- Participants who have evidence of distant or non-regional lymph node metastases, in-transit metastases, or positive lymph nodes with an unknown primary.
- Participants whose disease cannot be completely surgically resected because of gross extracapsular extension.
- Participants who have previously received interferon for any reason.
- Participants who have severe cardiovascular disease, i.e., arrhythmias requiring chronic treatment, congestive heart failure (New York Heart Association [NYHA] Class III or IV) or symptomatic ischemic heart disease.
- Participants who have a history of neuropsychiatric disorder requiring hospitalization.
- Participants with thyroid dysfunction not responsive to therapy.
- Participants with uncontrolled diabetes mellitus.
- Participants with a history of prior malignancy within the past 5 years other than surgically cured non-melanoma skin cancer or cervical carcinoma in situ.
- Participants who have a history of seropositivity for human immunodeficiency virus (HIV).
- Participants who are pregnant, lactating, or of reproductive potential and not practicing an effective means of contraception.
- Participants with active and/or uncontrolled infection, including active hepatitis.
- Participants with a medical condition requiring chronic systemic corticosteroids.
- Participants who are known to be actively abusing alcohol or drugs.
- Participants who have received any experimental therapy within 30 days prior to randomization in this study.
- Participants who have not recovered from the effects of recent surgery.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PEG-Intron
Participants with stage III node positive cutaneous melanoma will receive subcutaneous PEG-Intron (6.0 ug/kg weekly) for 2 years post-surgery.
|
Polyethylene glycol (PEG)12000 Interferon alfa 2-b subcutaneous injection.
Other Names:
|
Experimental: INTRON A
Participants with stage III node positive cutaneous melanoma will receive intravenous INTRON A (20 million international units [MIU]/m^2/day, 5 days a week) for 4 weeks followed by subcutaneous INTRON A (10 MIU/m^2 three times per week) for 48 weeks post-surgery.
|
Interferon alfa-2b, recombinant for intravenous injection.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival (PFS)
Time Frame: From time of randomization to time of progression or death (up to approximately 26 months)
|
Progression-free survival time was defined as the time from the date of randomization to the date of disease progression or the date of death regardless of the cause.
PFS was to be assessed by clinical observation, with recurrence documented by appropriate radiographic and histologic methods, and confirmed by Independent Central Review.
|
From time of randomization to time of progression or death (up to approximately 26 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: From time of randomization to time of death (up to approximately 26 months)
|
Overall survival (OS) is the time from randomization to death due to any cause.
Participants were to be followed for survival every 3 months.
Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up.
After the early termination of the study, participants were followed for safety only.
Although the OS analysis is not in the clinical study report due to early termination of the study, an OS ad hoc analysis was requested by the FDA and is therefore presented in this outcome measure.
Below table presents the median duration of survival for participants.
|
From time of randomization to time of death (up to approximately 26 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 5, 1998
Primary Completion (Actual)
February 19, 2001
Study Completion (Actual)
February 19, 2001
Study Registration Dates
First Submitted
May 29, 2018
First Submitted That Met QC Criteria
May 29, 2018
First Posted (Actual)
June 12, 2018
Study Record Updates
Last Update Posted (Actual)
July 24, 2019
Last Update Submitted That Met QC Criteria
July 16, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunologic Factors
- Interferons
- Interferon-alpha
- Interferon alpha-2
- Peginterferon alfa-2b
Other Study ID Numbers
- C98135
- MK-4031-002 (Other Identifier: Merck Protocol Number)
- C98-135 (Other Identifier: Schering-Plough Protocol Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Mucosal Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Ciliary Body and Choroid Melanoma, Small Size | Iris Melanoma | Metastatic Intraocular Melanoma | Recurrent Intraocular Melanoma | Stage IV Intraocular Melanoma | Stage IIIA Melanoma | Stage... and other conditionsUnited States
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Rutgers, The State University of New JerseyNational Cancer Institute (NCI); University of VirginiaCompletedStage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage III Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin Melanoma | Stage 0 Skin Melanoma | Stage I Skin Melanoma | Stage II Skin MelanomaUnited States
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Clinical Trials on PEG-Intron
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Fundación de Investigación Biomédica - Hospital...Haematology Service,Unknown
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Merck Sharp & Dohme LLCCompleted
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National Institute of Diabetes and Digestive and...Schering-Plough; Ortho Biotech Clinical Affairs, L.L.C.CompletedHepatitis CUnited States
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The Methodist Hospital Research InstituteSchering-PloughTerminatedCarcinoma, Renal CellUnited States
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Shanghai General Hospital, Shanghai Jiao Tong University...CompletedRecurrence | Hematological NeoplasmsChina
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Merck Sharp & Dohme LLCCompleted
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Merck Sharp & Dohme LLCTerminated